VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
FDA premarket approval P910077/S040 · decided 2003-12-17
Approval details
- PMA number
- P910077
- Supplement
- S040
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2003-07-16
- Decision date
- 2003-12-17
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR LABELING CHANGES SPECIFIC TO DEFIBRILLATOR IMPLANT TESTING CRITERIA.
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