AID-B/BR AND VENTAK ICD
FDA premarket approval P830060/S077 · decided 2014-05-02
Approval details
- PMA number
- P830060
- Supplement
- S077
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AID-B/BR AND VENTAK ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2014-02-21
- Decision date
- 2014-05-02
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL TO ADD THE USE OF MINERAL OIL TO DEVICE LABELING.
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