PMA P060027S093
- Device
- PLATINIUM 4LV CRT-D
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S093
- Product code
- NIK
- Decision date
- 2018-03-11
- 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 software updates to the embedded device and remote monitoring system.
Current openFDA PMA Record#
- Device
- PLATINIUM 4LV CRT-D
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S093
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-03-11
- Decision code
- APPR
- Date received
- 2018-01-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software updates to the embedded device and remote monitoring system.