CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER
FDA premarket approval P950029 · decided 1997-03-10
Approval details
- PMA number
- P950029
- Trade name
- CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 1995-08-02
- Decision date
- 1997-03-10
- Days to decision
- 586 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE CHORUS RM MODEL 7034 DDDR PACEMAKER SYSTEM AND OPUS RM MODEL 4534 SSIR PACEMAKER SYSTEM WHICH INCLUDES AN IBM COMPATIBLE MICROCOMPUTER WHICH HAS BEEN CONFIGURED AND FURNISHED BY ELA MEDICAL, INC. WITH CSO 2.46 PROGRAMMING SOFTWARE AND IS CONNECTED TO A CPR1 PROGRAMMING HEAD. THESE DEVICES ARE INDICATED FOR: RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION; AND THE GENERALLY ACCEPTED PATIENT CONDITIONS WA
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