VENTAK MINI AICD SYSTEM
FDA premarket approval P910077/S008 · decided 1995-12-21
Approval details
- PMA number
- P910077
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK MINI AICD SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1995-06-13
- Decision date
- 1995-12-21
- Days to decision
- 191 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE VENTAK MINI AICD SYSTEM, WHICH INCLUDES:MODEL NUMBERS 1645, 1740, 1741, 1745, AND 1746 PULSE GENERATORS; MODEL 2840 SOFTWARE APPLICATION; MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU); AND MODEL 6996 DF-1 PLUG
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