PMA P150033S162
- Device
- CareLink SmartSync™ Micra VR App, CareLink SmartSync™ Micra AV App
- Applicant
- Medtronic, Inc.
- Product code
- OSR
- Decision date
- 2023-01-18
- Generic name
- Pacemaker/icd/crt non-implanted components
- Approval order statement
- Approval for software updates to the CareLink SmartSync software application.
Current openFDA PMA Record#
- Device
- CareLink SmartSync™ Micra VR App, CareLink SmartSync™ Micra AV App
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S162
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- Decision date
- 2023-01-18
- Decision code
- APPR
- Date received
- 2022-11-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software updates to the CareLink SmartSync software application.