PMA P980049S102
- Device
- PARADYM RF VR 9250 PARADYM RF DR 9550
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P980049
- Supplement
- S102
- Product code
- OSR
- Decision date
- 2014-11-06
- Classification
- Pacemaker/icd/crt Non-implanted Components
- Generic name
- Pacemaker/icd/crt non-implanted components
- Approval order statement
- APPROVAL FOR A CHANGE TO THE SOFTWARE CODE FOR THE SMARTVIEW(HOME) MONITOR USED FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- PARADYM RF VR 9250 PARADYM RF DR 9550
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P980049
- Supplement
- S102
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- Decision date
- 2014-11-06
- Decision code
- APPR
- Date received
- 2014-09-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE TO THE SOFTWARE CODE FOR THE SMARTVIEW(HOME) MONITOR USED FOR THE DEVICES.