PMA P060027S088
- Device
- PLATINIUM VR 1210, 1240; DR 1510, 1540, CRT-D 1711, 1741 (IS1) and 1744 (IS4)
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S088
- Product code
- NIK
- Decision date
- 2017-10-26
- 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 feature and hardware changes to Platinium models.
Current openFDA PMA Record#
- Device
- PLATINIUM VR 1210, 1240; DR 1510, 1540, CRT-D 1711, 1741 (IS1) and 1744 (IS4)
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S088
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2017-10-26
- Decision code
- APPR
- Date received
- 2016-12-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for feature and hardware changes to Platinium models.