VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR
FDA premarket approval P910077 · decided 1994-06-17
Approval details
- PMA number
- P910077
- Trade name
- VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1991-12-23
- Decision date
- 1994-06-17
- Days to decision
- 907 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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