VENTAK(R) P3 AICD(TM) SYSTEM
FDA premarket approval P930035/S001 · decided 1995-09-08
Approval details
- PMA number
- P930035
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK(R) P3 AICD(TM) SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1994-11-10
- Decision date
- 1995-09-08
- Days to decision
- 302 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR VENTAK P3 W/VENTAK SOFTWARE MODULE, ENDOTAK C LEAD, ENDOTAK SQ PATCH LEAD, ENDOTAK SQ LEAD ARRAY, AICD Y CONNECTOR, EPICARDIAL PATCH LEAD; SOFTWARE MODULE MODEL 2836 REVISION 2.1 SOFTWARE; AND ALTERNATE STERILIZATION PROCESS
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.