- Device
- Platinium CRT-D and Platinium 4LV CRT-D
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S103
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2020-08-10
- Decision code
- OK30
- Date received
- 2020-07-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of automated equipment during the manufacturing of select pacemakers and defibrillators.