- Device
- Platinium CRT-D and Platinium 4LV CRT-D (Cardiac Resynchronization Therapy Defibrillator)
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S102
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2020-03-06
- Decision code
- OK30
- Date received
- 2020-02-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement sterilization cycle MicroPort01 at Steris SpA contactor.