RHAPSODY MODELS 2210, 2510 AND 2530 PACEMAKERS; SYMPHONY MODELS 2250 AND 2550 PACEMAKERS
FDA premarket approval P950029/S029 · decided 2006-09-22
Approval details
- PMA number
- P950029
- Supplement
- S029
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RHAPSODY MODELS 2210, 2510 AND 2530 PACEMAKERS; SYMPHONY MODELS 2250 AND 2550 PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2006-08-28
- Decision date
- 2006-09-22
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR A COUNTERBORE BEING ADDED TO THE CERAMIC INSULATOR TO ACCOMMODATE THE BRAZED GOLD FOR EACH FEEDTHROUGH WIRE.
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