PMA P980049S129
- Device
- Platinium VR 1240; Platinium DR 1540
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P980049
- Supplement
- S129
- Product code
- MRM
- Decision date
- 2018-03-20
- Classification
- Defibrillator, Implantable, Dual-chamber
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- Supplier manufacturing change for contact spring components assembled into headers.
Current openFDA PMA Record#
- Device
- Platinium VR 1240; Platinium DR 1540
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P980049
- Supplement
- S129
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2018-03-20
- Decision code
- OK30
- Date received
- 2018-02-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Supplier manufacturing change for contact spring components assembled into headers.