Paradym and Paradym RF, Update to Platinium Embedded Software
FDA premarket approval P060027/S090 · decided 2017-07-26
Approval details
- PMA number
- P060027
- Supplement
- S090
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Paradym and Paradym RF, Update to Platinium Embedded Software
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2017-05-22
- Decision date
- 2017-07-26
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for updates to the embedded software and programmer module software.
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