PMA P010032S062

Device
PENTA LEAD SERIES
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S062
Product code
LGW
Decision date
2012-08-31
Classification
Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
CHANGE THE IN- PROCESS DIMENSIONAL INSPECTION FOR THE DEVICES.

Current openFDA PMA Record#

Device
PENTA LEAD SERIES
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S062
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2012-08-31
Decision code
OK30
Date received
2012-08-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE THE IN- PROCESS DIMENSIONAL INSPECTION FOR THE DEVICES.