OPUS RM 4534 AND CHORUS RM 7034 PACEMAKERS
FDA premarket approval P950029/S003 · decided 1998-11-18
Approval details
- PMA number
- P950029
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OPUS RM 4534 AND CHORUS RM 7034 PACEMAKERS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 1998-09-10
- Decision date
- 1998-11-18
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for a sterilization site located at Griffith MicroScience S.A., 8 rue Parmentier, 60290 Rantigny, France.
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