PMA P890003S451

Device
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead
Applicant
Medtronic, Inc.
PMA number
P890003
Supplement
S451
Product code
NVZ
Decision date
2022-01-28
Generic name
Pulse generator, permanent, implantable
Approval order statement
Minor modifications to combination product processes at Medtronic Rice Creek.

Current openFDA PMA Record#

Device
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead
Applicant
Medtronic, Inc.
PMA number
P890003
Supplement
S451
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2022-01-28
Decision code
OK30
Date received
2022-01-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Minor modifications to combination product processes at Medtronic Rice Creek.