PMA P030017S069

Device: PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
Applicant: Boston Scientific Corp
PMA number: P030017
Supplement: S069
Product code: LGW
Decision date: 2009-02-20
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 MODIFICATION TO THE IMPLANTABLE PULSE GENERATOR (IPG) TEST PROCEDURE TO INCLUDE THE ADDITION OF A NEW PIECE OF EQUIPMENT.

Current openFDA PMA Record#

Device: PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
Applicant: Boston Scientific Corp
PMA number: P030017
Supplement: S069
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2009-02-20
Decision code: APPR
Date received: 2008-09-04
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MODIFICATION TO THE IMPLANTABLE PULSE GENERATOR (IPG) TEST PROCEDURE TO INCLUDE THE ADDITION OF A NEW PIECE OF EQUIPMENT.