VENTAK(R) PRX (TM) II AICD SYSTEM
FDA premarket approval P910077/S011 · decided 1996-02-05
Approval details
- PMA number
- P910077
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Trade name
- VENTAK(R) PRX (TM) II AICD SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1995-08-25
- Decision date
- 1996-02-05
- Days to decision
- 164 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE USE OF MODEL 2872 SOFTWARE APPLICATION, REV. 4.1 AND MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU) WITH THE VENTAK PRX II/III PULSE GENERATOR AND MODEL 2950 PRM
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