AID (R) B/BR HIGH VOLTAGE CABLES FOR ECD SYSTEMS
FDA premarket approval P830060/S029 · decided 1991-12-26
Approval details
- PMA number
- P830060
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AID (R) B/BR HIGH VOLTAGE CABLES FOR ECD SYSTEMS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1991-11-22
- Decision date
- 1991-12-26
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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