ENDOTAK LEAD SYSTEM
FDA premarket approval P910073 · decided 1993-08-26
Approval details
- PMA number
- P910073
- Trade name
- ENDOTAK LEAD SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1991-12-19
- Decision date
- 1993-08-26
- Days to decision
- 616 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the 0060 Series ENDOTAK® Lead System. The ENDOTAK® Lead System (hereafter referred to as the ENDOTAK® Lead System) consists of the following: the ENDOTAK® C Lead Models 0060, 0062, 0064; Lead Stylet Models 6824 and 6825; ENDOTAK® SQ Patch Lead Model 0063; commercially available AICD Y Connector Model 6836; and Model 0056 Bipolar Positive Fixation Lead and Adapter. The ENDOTAK® Lead System is used with commercially available AICD Models 15050, 1555, and 1600. The ENDOTAK® Lead Syst
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