PMA P030017S155

Device
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S155
Product code
LGW
Decision date
2013-03-15
Classification
Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
USE ALTERNATE BIOLOGICAL INDICATORS FOR MONITORING ETHYLENE OXIDE STERILIZATION.

Current openFDA PMA Record#

Device
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S155
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2013-03-15
Decision code
OK30
Date received
2013-02-15
Supplement type
30-Day Notice
Approval order statement
USE ALTERNATE BIOLOGICAL INDICATORS FOR MONITORING ETHYLENE OXIDE STERILIZATION.