VENTAK MINI ACID FAMILY SYSTEMS
FDA premarket approval P910077/S025 · decided 1998-12-02
Approval details
- PMA number
- P910077
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK MINI ACID FAMILY SYSTEMS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1998-09-10
- Decision date
- 1998-12-02
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for VENTAK(R) MINI(TM) IV Models 1790, 1792, 1793, and 1796; VENTAK(R) MINI(TM) III+HE Models 1788 and 1789; VENTAK(R) MINI(TM) Application Software Model 2840 (Version 4.0); and the sensitivity adjustment for VENTAK(R) MINI(TM) and MINI(TM) II ICD systems.
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