PMA P890003S446
- Device
- CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S446
- Product code
- NVZ
- Decision date
- 2021-06-23
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- Changes to the cleaning process of stylet components manufactured at the supplier.
Current openFDA PMA Record#
- Device
- CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S446
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2021-06-23
- Decision code
- OK30
- Date received
- 2021-06-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the cleaning process of stylet components manufactured at the supplier.