PLATINIUM VR 1210; PLATINIUM VR 1240; PLATINIUM DR 1510; PLATINIUM DR 1540; PLATINIUM CRT-D 1711; PLATINIUM CRT-D 1741;
FDA premarket approval P980049/S133 · decided 2019-03-19
Approval details
- PMA number
- P980049
- Supplement
- S133
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PLATINIUM VR 1210; PLATINIUM VR 1240; PLATINIUM DR 1510; PLATINIUM DR 1540; PLATINIUM CRT-D 1711; PLATINIUM CRT-D 1741;
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2018-12-20
- Decision date
- 2019-03-19
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for updates to the embedded device software.
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