SYMPHONY & ELA RHAPSODY PACEMAKERS
FDA premarket approval P950029/S021 · decided 2004-10-27
Approval details
- PMA number
- P950029
- Supplement
- S021
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SYMPHONY & ELA RHAPSODY PACEMAKERS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2004-10-07
- Decision date
- 2004-10-27
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE SYMPHONY AND ELA RHAPSODY PACEMAKERS TO INCLUDE INSTRUCTIONS ABOUT TESTING, SENSING OR PACING WHILE THE PACEMAKER IS OUT OF THE POCKET.
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