PMA P890003S447

Device
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead
Applicant
Medtronic, Inc.
PMA number
P890003
Supplement
S447
Product code
NVZ
Decision date
2021-08-17
Generic name
Pulse generator, permanent, implantable
Approval order statement
Minor modifications, including new ovens and a new toolmaker's scope 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
S447
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2021-08-17
Decision code
OK30
Date received
2021-08-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Minor modifications, including new ovens and a new toolmaker's scope at Medtronic Rice Creek.