PMA P010032S080

Device
OCTRODE LEADS
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S080
Product code
LGW
Decision date
2014-06-27
Classification
Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
IMPLEMENT CHANGES TO THE TESTING AND INSPECTION PROCESS.

Current openFDA PMA Record#

Device
OCTRODE LEADS
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S080
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2014-06-27
Decision code
OK30
Date received
2014-05-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
IMPLEMENT CHANGES TO THE TESTING AND INSPECTION PROCESS.