VENTAK(R) MINI HC(HOT CAN) AICD SYSTEM
FDA premarket approval P910077/S012 · decided 1996-04-29
Approval details
- PMA number
- P910077
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Trade name
- VENTAK(R) MINI HC(HOT CAN) AICD SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1995-09-12
- Decision date
- 1996-04-29
- Days to decision
- 230 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE VENTAK MINI HC (MODELS 1742, 1743, AND 1640) WHICH IS AN ACTIVE CAN VERSION OF YOUR COMMERCIALLY AVAILABLE VENTAK MINI AICD SYSTEM AND THE VENTAK MINI II HC AICD SYSTEM (MODELS 1652, 1662, 1752, 1762, 1753, AND 1763) WHICH IS A DOWN-SIZED VERSION OF THE VENTAK MINI HC AICD SYSTEM. THE MINI II HC MAXIMUM ENERGY LEVELS ARE 25 AND 27 JEWELS WHERE THE MINI HC MAXIMUM ENERGY LEVEL IS 29 JEWELS
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