PMA P890003S452

Device: CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit, Vitatron Brilliant S+ VDD Lead
Applicant: Medtronic, Inc.
PMA number: P890003
Supplement: S452
Product code: NVZ
Decision date: 2022-04-21
Generic name: Pulse generator, permanent, implantable
Approval order statement: Updates to the equipment used for monitoring temperature and humidity in Controlled Environment Area number 2 at Medtronic Rice Creek.

Current openFDA PMA Record#

Device: CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit, Vitatron Brilliant S+ VDD Lead
Applicant: Medtronic, Inc.
PMA number: P890003
Supplement: S452
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2022-04-21
Decision code: OK30
Date received: 2022-04-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Updates to the equipment used for monitoring temperature and humidity in Controlled Environment Area number 2 at Medtronic Rice Creek.