PMA P890003S486
- Device
- CapSure VDD-2 Lead (5038L, 5038S), CapSure VDD-2 Lead (5038), Service Kit-Pacemaker Repair Kit (5873C)
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S486
- Product code
- NVZ
- Decision date
- 2026-04-15
- Classification
- Cardiovascular
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- to reduce the bioburden monitoring frequency from bi-weekly to monthly
Current openFDA PMA Record#
- Device
- CapSure VDD-2 Lead (5038L, 5038S), CapSure VDD-2 Lead (5038), Service Kit-Pacemaker Repair Kit (5873C)
- Applicant
- Medtronic, Inc.
- PMA number
- P890003
- Supplement
- S486
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2026-04-15
- Decision code
- OK30
- Date received
- 2026-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to reduce the bioburden monitoring frequency from bi-weekly to monthly