PLATINIUM 4LV CRT-D
FDA premarket approval P060027/S093 · decided 2018-03-11
Approval details
- PMA number
- P060027
- Supplement
- S093
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PLATINIUM 4LV CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- 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
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for software updates to the embedded device and remote monitoring system.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.