PMA P990001S115

Device
VITATRON C20 SR IPG; C60 DR IPG; T20 SR IPG; T60 DR IPG
Applicant
Medtronic, Inc.
PMA number
P990001
Supplement
S115
Product code
NVZ
Decision date
2013-08-22
Generic name
Pulse generator, permanent, implantable
Approval order statement
ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.

Current openFDA PMA Record

Device
VITATRON C20 SR IPG; C60 DR IPG; T20 SR IPG; T60 DR IPG
Applicant
Medtronic, Inc.
PMA number
P990001
Supplement
S115
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2013-08-22
Decision code
OK30
Date received
2013-07-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE SUPPLIERS FOR MOLDED SILICONE COMPONENTS.

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