PMA P150033S096
- Device
- CareLink SmartSync Micra VR/AV Application
- Applicant
- Medtronic, Inc.
- Product code
- PNJ
- Decision date
- 2021-05-27
- Generic name
- Leadless pacemaker
- Approval order statement
- Approval for new cardiovascular implantable electronic device (CIED) software applications on the CareLink SmartSync Device Manager.
Current openFDA PMA Record#
- Device
- CareLink SmartSync Micra VR/AV Application
- Applicant
- Medtronic, Inc.
- PMA number
- P150033
- Supplement
- S096
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2021-05-27
- Decision code
- APPR
- Date received
- 2021-03-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for new cardiovascular implantable electronic device (CIED) software applications on the CareLink SmartSync Device Manager.