SYMPHONY DR/SR & ELA RHAPSODY +DR/DR/SR
FDA premarket approval P950029/S037 · decided 2008-07-23
Approval details
- PMA number
- P950029
- Supplement
- S037
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SYMPHONY DR/SR & ELA RHAPSODY +DR/DR/SR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2008-06-23
- Decision date
- 2008-07-23
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR MANUFACTURING PROCESS CHANGES ENHANCING THE QUALITY CONTROLS PERTAINING TO SYMPHONY AND RHAPSODY PACEMAKERS AS WELL AS OVATIO ICD AND CRT-D SYSTEM DEVICES.
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