FDA.reportPublic FDA data

PMA P010032S157

Device
Paddle Leads
Applicant
ABBOTT MEDICAL
Product code
LGW
Decision date
2021-02-22
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Approval to add Abbott Medical Puerto Rico facility located at Km 67.5 Rd2 Arecibo, Puerto Rico, 00612 as an alternate sterilization and manufacturing site of the Paddle Lead and Internal Lead Extension products.

Current openFDA PMA Record#

Device
Paddle Leads
Applicant
ABBOTT MEDICAL
PMA number
P010032
Supplement
S157
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2021-02-22
Decision code
APPR
Date received
2019-11-27
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval to add Abbott Medical Puerto Rico facility located at Km 67.5 Rd2 Arecibo, Puerto Rico, 00612 as an alternate sterilization and manufacturing site of the Paddle Lead and Internal Lead Extension products.