- Device
- Platinium VR and Platinium DR ICDs (Implantable Cardioverter Defibrillator) and Orchestra Plus Link
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P980049
- Supplement
- S140
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2020-10-20
- Decision code
- OK30
- Date received
- 2020-09-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate equipment to be used for microelectronic and Surface Mount Technology assembly.