COSMOS(TM) SYSTEM
FDA premarket approval P830026/S019 · decided 1987-02-03
Approval details
- PMA number
- P830026
- Supplement
- S019
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Other
- Trade name
- COSMOS(TM) SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1986-09-26
- Decision date
- 1987-02-03
- Days to decision
- 130 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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