PMA P980049S128
- Device
- PLATINIUM VR / DR / CRT-D
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P980049
- Supplement
- S128
- Product code
- MRM
- Decision date
- 2018-03-11
- Classification
- Defibrillator, Implantable, Dual-chamber
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- Approval for software updates to the embedded device and remote monitoring system.
Current openFDA PMA Record#
- Device
- PLATINIUM VR / DR / CRT-D
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P980049
- Supplement
- S128
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2018-03-11
- Decision code
- APPR
- Date received
- 2018-01-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software updates to the embedded device and remote monitoring system.