COSMOS(TM) SYSTEM
FDA premarket approval P830026/S026 · decided 1987-06-26
Approval details
- PMA number
- P830026
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COSMOS(TM) SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1987-03-11
- Decision date
- 1987-06-26
- Days to decision
- 107 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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