VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
FDA premarket approval P910077/S027 · decided 1999-03-17
Approval details
- PMA number
- P910077
- Supplement
- S027
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK MINI AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1999-02-17
- Decision date
- 1999-03-17
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a design and manufacturing change to the pulse generator hybrid assembly for the VENTAK(R) MINI III(TM) and MINI IV(TM) AICD(TM) Systems (Models 1782, 1783, 1786, 1788, 1789, 1790, 1792, 1793, and 1796).
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