CHORUS(R) MODEL 6001,3,33 DDD MODEL CPRI MODEL P2A
FDA premarket approval P900022/S003 · decided 1992-03-13
Approval details
- PMA number
- P900022
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CHORUS(R) MODEL 6001,3,33 DDD MODEL CPRI MODEL P2A
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 1991-11-07
- Decision date
- 1992-03-13
- Days to decision
- 127 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
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