Platinium, Paradym RF, RF VR, RF DR, Intensia CRT-Ds
FDA premarket approval P060027/S083 · decided 2016-09-27
Approval details
- PMA number
- P060027
- Supplement
- S083
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Platinium, Paradym RF, RF VR, RF DR, Intensia CRT-Ds
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2016-07-21
- Decision date
- 2016-09-27
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for Remote Monitoring System software version 3.7.
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