ENDOTAK SQ LEAD ARRAY MODEL 0048 AND ENDOTAK SQ LEAD PATCH MODEL 0063
FDA premarket approval P910073/S016 · decided 1996-04-04
Approval details
- PMA number
- P910073
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDOTAK SQ LEAD ARRAY MODEL 0048 AND ENDOTAK SQ LEAD PATCH MODEL 0063
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1995-05-12
- Decision date
- 1996-04-04
- Days to decision
- 328 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ALTERNATIVE MANUFACTURING SITE: CARDIAC PACEMAKERS, INC., DEL CARIBE, ROAD 698 LOT NO. 12, DORADO, PUERTO RICO 00646
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