PMA P970012S055

Device
KAPPA 400 DR IPG/KAPPA 400 SR IPG
Applicant
Medtronic, Inc.
PMA number
P970012
Supplement
S055
Product code
NVZ
Decision date
2009-07-10
Classification
Pulse Generator, Permanent, Implantable
Generic name
Pulse generator, permanent, implantable
Approval order statement
ADDITION OF A NEW STERILIZER AND AERATOR.

Current openFDA PMA Record#

Device
KAPPA 400 DR IPG/KAPPA 400 SR IPG
Applicant
Medtronic, Inc.
PMA number
P970012
Supplement
S055
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2009-07-10
Decision code
OK30
Date received
2009-06-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A NEW STERILIZER AND AERATOR.