COSMOS(R)II,NOVA(R)II,QUANTUM(R)II, & RX2000(R)
FDA premarket approval P830026/S054 · decided 1992-12-29
Approval details
- PMA number
- P830026
- Supplement
- S054
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COSMOS(R)II,NOVA(R)II,QUANTUM(R)II, & RX2000(R)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1992-05-11
- Decision date
- 1992-12-29
- Days to decision
- 232 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
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