CHORUS PACEMAKERS
FDA premarket approval P900022/S005 · decided 1998-11-18
Approval details
- PMA number
- P900022
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CHORUS PACEMAKERS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 1998-09-11
- Decision date
- 1998-11-18
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- LWP
- 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
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.