SYMPHONY AND ELA RHAPSODY PACEMAKERS
FDA premarket approval P950029/S020 · decided 2004-07-15
Approval details
- PMA number
- P950029
- Supplement
- S020
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYMPHONY AND ELA RHAPSODY PACEMAKERS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2004-06-07
- Decision date
- 2004-07-15
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR UNCOATED VERSIONS OF THE SYMPHONY AND ELA RHAPSODY PACEMAKERS.
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