SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM
FDA premarket approval P950029/S017 · decided 2003-10-24
Approval details
- PMA number
- P950029
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2002-12-23
- Decision date
- 2003-10-24
- Days to decision
- 305 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR NEW PACEMAKER MODELS, SYMPHONY MODELS 2550, AND 2250 AND ELA RHAPSODY MODELS 2530, 2510 AND 2210. THE SYMPHONY AND ELA RHAPSODY PACEMAKER SYSTEMS ARE INDICATED FOR: 1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION AND/OR ACTIVITY. 2) THE ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE, BUT ARE NOT RESTRICTED TO: A) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND- OR THIRD-DEGREE AV
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