PMA P850051S075

Device
VITATRON LEGACY IPG
Applicant
Medtronic, Inc.
PMA number
P850051
Supplement
S075
Product code
LWO
Decision date
2011-07-07
Generic name
Pulse-generator, single chamber, sensor driven, implantable
Approval order statement
UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).

Current openFDA PMA Record

Device
VITATRON LEGACY IPG
Applicant
Medtronic, Inc.
PMA number
P850051
Supplement
S075
Product code
LWO
Generic name
Pulse-generator, single chamber, sensor driven, implantable
Decision date
2011-07-07
Decision code
OK30
Date received
2011-06-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
UPGRADE TO STATISTICAL PROCESS CONTROL OFF-THE-SHELF SOFTWARE THAT WILL BE USED BY MEDTRONIC ENERGY AND COMPONENT CENTER (MECC).

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