PMA P890003S484
- Device
- CapSure VDD-2 Lead 5038, 5038L, 5038S Service Kit-Pacemaker Repair Kit 5873C Vitatron Brilliant S+ VDD Lead IMW14Q, IMW1
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S484
- Product code
- NVZ
- Decision date
- 2026-02-10
- Classification
- Cardiovascular
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- a new vapor degreasing solvent
Current openFDA PMA Record#
- Device
- CapSure VDD-2 Lead 5038, 5038L, 5038S Service Kit-Pacemaker Repair Kit 5873C Vitatron Brilliant S+ VDD Lead IMW14Q, IMW1
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S484
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2026-02-10
- Decision code
- OK30
- Date received
- 2026-01-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new vapor degreasing solvent