PMA P980049S138
- Device
- Platinium VR and Platinium DR ICDs
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P980049
- Supplement
- S138
- Product code
- MRM
- Decision date
- 2020-08-10
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- Introduction of automated equipment during the manufacturing of select pacemakers and defibrillators.
Current openFDA PMA Record#
- Device
- Platinium VR and Platinium DR ICDs
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P980049
- Supplement
- S138
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- 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.