VENTAK MINI IV (AICD)
FDA premarket approval P910077/S035 · decided 2000-12-06
Approval details
- PMA number
- P910077
- Supplement
- S035
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK MINI IV (AICD)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2000-11-07
- Decision date
- 2000-12-06
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE MODIFICATION OF THE MINI(TM) IV AICD(TM) HEADER AND REMOVING THE STERILE MINERAL OIL AND HEX WRENCH FROM THE PACKAGE.
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