PMA P890003S483
- Device
- CareLink SmartSync Device Manager Base 24970A
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S483
- Product code
- NVZ
- Decision date
- 2025-12-03
- Classification
- Cardiovascular
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- an update to the substrate defect mapping process
Current openFDA PMA Record#
- Device
- CareLink SmartSync Device Manager Base 24970A
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S483
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2025-12-03
- Decision code
- OK30
- Date received
- 2025-11-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an update to the substrate defect mapping process