SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM AND THE ORCHESTRA PROGRAMMER
FDA premarket approval P950029/S024 · decided 2005-09-02
Approval details
- PMA number
- P950029
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM AND THE ORCHESTRA PROGRAMMER
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2005-07-05
- Decision date
- 2005-09-02
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE FOLLOWING SOFTWARE UPDATES: 1) AAISAFER RAM PATCH 2.3 FOR SYMPHONY DR 2550 DEVICES WITH ROM MASK T3, 2) ROM MASK T4 FOR SYMPHONY DR 2550, SYMPHONY SR 2250, ELA RHAPSODY+ DR 2530, ELA RHAPSODY DR 2510, AND ELA RHAPSODY SR 2210, 3) ELAVIEW 1.30 UG2 APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER.
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