PARADYM RF:MODELS VR 9250, DR 9550, CRT-D 9750; PARADYM MODELS VR 8250, DR 8550, CRT-D 8750
FDA premarket approval P060027/S053 · decided 2014-03-06
Approval details
- PMA number
- P060027
- Supplement
- S053
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PARADYM RF:MODELS VR 9250, DR 9550, CRT-D 9750; PARADYM MODELS VR 8250, DR 8550, CRT-D 8750
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2013-08-21
- Decision date
- 2014-03-06
- Days to decision
- 197 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR:1) A FIRMWARE PATCH FOR THE IMPLANTABLE DEVICE WITH THE MICROPROCESSOR (UP) V4B; 2) A NEW FIRMWARE VERSION FOR THE UP V4C AND V4D; 3) THE HARDWARE MODIFICATIONS FOR THE IMPLANTABLE DEVICES; 4) THE UPDATES/ MODIFICATIONS FOR THE PROGRAMMER APPLICATION SOFTWARE; AND 5) THE UPDATES/ MODIFICATIONS FOR THE REMOTE MONITORING SYSTEM (RMS).
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