PMA P010032S132

Device: Proclaim Family of Implantable Pulse Generators
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S132
Product code: LGW
Decision date: 2018-03-11
Classification: Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for a manufacturing site located at St. Jude Medical-Puerto Rico, Lot A Interior-No. 2 St. Km 67.5, Santana Industrial Park, Arecibo, Puerto Rico for manufacturing and sterilization of the Proclaim and Infinity neurostimulation systems.

Current openFDA PMA Record#

Device: Proclaim Family of Implantable Pulse Generators
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S132
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2018-03-11
Decision code: APPR
Date received: 2017-07-28
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at St. Jude Medical-Puerto Rico, Lot A Interior-No. 2 St. Km 67.5, Santana Industrial Park, Arecibo, Puerto Rico for manufacturing and sterilization of the Proclaim and Infinity neurostimulation systems.