PMA P980049S123
- Device
- PLATINIUM VR 1210, 1240; DR 1510, 1540, CRT-D 1711, 1741
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P980049
- Supplement
- S123
- Product code
- MRM
- Decision date
- 2017-10-26
- Classification
- Defibrillator, Implantable, Dual-chamber
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- Approval for feature and hardware changes to Platinium models.
Current openFDA PMA Record#
- Device
- PLATINIUM VR 1210, 1240; DR 1510, 1540, CRT-D 1711, 1741
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P980049
- Supplement
- S123
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2017-10-26
- Decision code
- APPR
- Date received
- 2016-12-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for feature and hardware changes to Platinium models.