VENTAK PRX AICD, VENTAK PRX II AICD, VENTAK PRX III AICD, VENTAK MINI AICD, VENTAK MINI HC AICD, VENTAK II AICD
FDA premarket approval P910077/S015 · decided 1996-05-15
Approval details
- PMA number
- P910077
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VENTAK PRX AICD, VENTAK PRX II AICD, VENTAK PRX III AICD, VENTAK MINI AICD, VENTAK MINI HC AICD, VENTAK II AICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1996-05-10
- Decision date
- 1996-05-15
- Days to decision
- 5 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE VENTAK PRX AICD (MODELS 1700 AND 1705), VENTAK PRX II AICD MODEL 1715, VENTAK PRX III AICD (MODELS 1720 AND 1725), VENTAK MINI AICD (MODELS 1645, 1740, 1741, 1745, AND 1746), VENTAK MINI HC AICD (MODELS 1742, 1743 AND 1640), AND VENTAK MINI AICD (MODELS 1652, 1662, 1752, 1762, 1753, AND 1763) WHICH REQUESTED APPROVAL TO ADD A PATIENT GROUP TO THE INDICATIONS FOR USE
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