PLATINIUM VR / DR / CRT-D
FDA premarket approval P980049/S128 · decided 2018-03-11
Approval details
- PMA number
- P980049
- Supplement
- S128
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PLATINIUM VR / DR / CRT-D
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2018-01-03
- Decision date
- 2018-03-11
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for software updates to the embedded device and remote monitoring system.
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