PMA P060027S098
- Device
- PLATINIUM VR 1210; PLATINIUM VR 1240; PLATINIUM DR 1510; PLATINIUM DR 1540; PLATINIUM CRT-D 1711; PLATINIUM CRT-D 1741;
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S098
- Product code
- NIK
- Decision date
- 2019-03-19
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Approval for updates to the embedded device software.
Current openFDA PMA Record#
- Device
- PLATINIUM VR 1210; PLATINIUM VR 1240; PLATINIUM DR 1510; PLATINIUM DR 1540; PLATINIUM CRT-D 1711; PLATINIUM CRT-D 1741;
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S098
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2019-03-19
- Decision code
- APPR
- Date received
- 2018-12-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updates to the embedded device software.