PARADYM RF CRT-D9750
FDA premarket approval P060027/S065 · decided 2014-06-27
Approval details
- PMA number
- P060027
- Supplement
- S065
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PARADYM RF CRT-D9750
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2014-04-24
- Decision date
- 2014-06-27
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR MINOR DESIGN CHANGES TO THE SRAM AND ZENER DIODESFOR THE DEVICES.
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