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Greatbatch medical myopore

WebGreatbatch Medical's current product line of pacing leads is composed of permanent, sutureless, epicardial leads (MyoPore®) and an innovative implant tool (FasTac™). Greatbatch Medical offers both unipolar and bipolar models in a number of different lengths from 25cm to 54cm. WebJan 1, 2012 · FasTac ® Flex tool works in conjunction with the Greatbatch MyoPore ® line of sutureless leads to provide remote distal deflection capabilities, remote lead rotation for insertion of the helix into the myocardium, remote lead release and the possibility of regrasping the lead button Full size image

MAUDE - Manufacturer and User Facility Device Experience

WebInteger Holdings Corporation manufactures medical products. The Company offers surgical, orthopedic, neuromodulation, cardio, vascular, and electrochem products. Greatbatch … WebThe myopore bipolar epicardial leads packaging is labeled as unipolar leads. the lead body itself is correctly labeled as bipolar. this could result in a bipolar lead being implanted with a pulse generator operating in unipolar mode. ... Greatbatch Medical issued an Urgent Medical Device Recall letter dated May 13, 2010 to their distributor ... dr mallay occhiogrosso https://consival.com

Premarket Approval (PMA)

WebGREATBATCH MEDICAL: 511212-Each-EXPIRED. GREATBATCH MEDICAL MYOPORE BIPOLAR SUTURELESS PACING LEAD 54CM EXPIRED. $109.00. Unit of Measure. Quantity. WebWilson Greatbatch, co-inventor of the first successful implanted pacemaker, founded Greatbatch, Inc. in 1970 to develop long-lived primary batteries to fuel pacemakers. His … WebThe Greatbatch Medical Myopore® Bipolar Sutureless Myocardial Pacing Lead is designed for long term ventricular pacing and sensing. The FasTac® Introducer aids attachment … colby mcclure greenwich ct

International Medical Devices Database

Category:International Medical Devices Database

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Greatbatch medical myopore

Miscellaneous - eSutures - The Suture Superstore

WebProduct Description. enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector, , REF 511212. 54 cm. Distributed by Guidant/CPI. Contents in unopened, undamaged package have been sterilized by ethylene oxide gas. Manufactured by enpath medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN … WebNov 8, 2024 · Steroid eluting (SE) group: 21 patients (Myodex™ 1084 T; St. Jude Medical) and non-steroid eluting (NSE) group: 11 patients (MyoPore® 511,212; Greatbatch …

Greatbatch medical myopore

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WebThe medical device MYOPORE is realized by GREATBATCH MEDICAL. Trade name. MYOPORE. Product Code. 511210; 511211; 511212. Manufacturer of the medical device. GREATBATCH MEDICAL. Category Name. PERMANENT CARDIAC ELECTROCATHETERS, EPICARDIAL. WebMyoPore ® Sutureless Bipolar Epicardial Pacing Lead Key Features: Platinized 10mm 2 electrode; Available in 25, 35 and 54 cm lengths with IS-1 connectors; Low profile construction for reduced electrode head size; …

WebApr 30, 2015 · The Myopore Leads have been marketed in the European Union (CE Mark) since 1996 and in Canada under a Medical Device License, which was granted by … WebGreatbatch Medical, 2300 Berkshire Lane North, Minneapolis MN 55441 Manufacturer Parent Company (2024) Integer Holdings Corporation Source USFDA 4 Events Recall of …

WebDuring our 80-year legacy of cutting-edge medical device manufacturing and medical device development, we have established a solid patient-focused foundation in cardiac rhythm, … WebOct 6, 2015 · Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ... P130012, FDA–2015–M–1557 Greatbatch Medical ..... Myopore Sutureless Myocardial Pacing Lead ..... 4/30/2015 P140023 ...

WebMYOPORE: Product Code: 511210; 511211; 511212: Manufacturer of the medical device: GREATBATCH MEDICAL: Category Name: PERMANENT CARDIAC …

WebGreatbatch Medical offers both unipolar and bipolar models in a number of different lengths from 25cm to 54cm. This epicardial lead technology has been on the market for 15 years … dr malley dds toledodr mallette dermatology athens alWebThe FasTac™ Flex works in conjunction with Greatbatch Medical's MyoPore® line of sutureless epicardial leads to provide you with remote distal deflection capabilities, remote lead rotation for insertion of the helix into the myocardium, and remote lead release and regrasping capabilities. More products from this supplier dr malliah cherry hill njWebGREATBATCH MEDICAL: 511212 – Expired Surgical Devices We have 3 in stock. GREATBATCH MEDICAL: 511212-Each-EXPIRED GREATBATCH MEDICAL … dr mallette podiatry melbourne flWebThe FlowGuard valved peelable introducer reduces air embolism by 99% over pinched-sheath technique.1 The proprietary valve allows for easy passage of vascular access catheters and pacing leads, while reducing the likelihood of blood loss. STEADY PERFORMANCE • Sliding valve feature enhances procedural... colby mayes architectWebGreatbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441 USA. The OptiSeal Valved PTFE Peelable Introducer is designed to reduce blood loss and air intake by providing hemostatic sealing at venous pressures. colby masvidalWebOct 6, 2015 · Greatbatch Medical: Myopore Sutureless Myocardial Pacing Lead: 4/30/2015: P140023, FDA-2015-M-1708: Roche Molecular Systems, Inc: cobas® KRAS Mutation Test ... Silk Road Medical, Inc: ENROUTE TM Transcarotid Stent System: 5/18/2015: P140004, FDA-2015-M-1957: Vertiflex®, Inc: Superion® InterSpinous … colby mcmorris