PMA P890003S453

Device
Patient Connector
Applicant
Medtronic, Inc.
PMA number
P890003
Supplement
S453
Product code
NVZ
Decision date
2022-04-28
Generic name
Pulse generator, permanent, implantable
Approval order statement
New automated equipment for mixing, coating, and rolling processes for lithium-ion batteries.

Current openFDA PMA Record#

Device
Patient Connector
Applicant
Medtronic, Inc.
PMA number
P890003
Supplement
S453
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2022-04-28
Decision code
OK30
Date received
2022-04-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New automated equipment for mixing, coating, and rolling processes for lithium-ion batteries.