PMA P890003S212

Device
PRODIGY
Applicant
Medtronic, Inc.
PMA number
P890003
Supplement
S212
Product code
NVZ
Decision date
2011-02-24
Classification
Pulse Generator, Permanent, Implantable
Generic name
Pulse generator, permanent, implantable
Approval order statement
REVISION OF PARAMETERS TO AN EPOXY DISPENSE MANUFACTURING PROCESS.

Current openFDA PMA Record#

Device
PRODIGY
Applicant
Medtronic, Inc.
PMA number
P890003
Supplement
S212
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2011-02-24
Decision code
OK30
Date received
2011-01-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
REVISION OF PARAMETERS TO AN EPOXY DISPENSE MANUFACTURING PROCESS.