PMA P980035S684
- Device
- CareLink SmartSync Azure Astra Application
- Applicant
- Medtronic, Inc.
- Product code
- NVZ
- Decision date
- 2021-08-16
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- Approval for the CareLink SmartSync MRI Access Application.
Current openFDA PMA Record#
- Device
- CareLink SmartSync Azure Astra Application
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S684
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2021-08-16
- Decision code
- APPR
- Date received
- 2021-05-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the CareLink SmartSync MRI Access Application.