|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Applicant||BOSTON SCIENTIFIC CORP.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Use alternate biological indicators for monitoring ethylene oxide sterilization.