AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL
FDA premarket approval P830060/S004 · decided 1986-10-03
Approval details
- PMA number
- P830060
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1986-09-16
- Decision date
- 1986-10-03
- Days to decision
- 17 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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