SYMPHONY & ELA RHAPSODY PACEMAKERS
FDA premarket approval P950029/S033 · decided 2008-02-13
Approval details
- PMA number
- P950029
- Supplement
- S033
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYMPHONY & ELA RHAPSODY PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2008-01-14
- Decision date
- 2008-02-13
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR AN ADDITION INSPECTION STEP TO WEIGH THE FINAL DEVICE AFTER MANUFACTURING OF THE DEVICES.
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