Premarket Approval (PMA)

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
• Classification Name: stimulator, spinal-cord, totally implanted for pain relief
• Applicant: BOSTON SCIENTIFIC CORP.
• PMA Number: P030017
• Supplement Number: S134
• Date Received: 05/07/2012
• Decision Date: 12/21/2012
• Product Code: LGW [ Registered Establishments with LGW ]
• Advisory Committee: Neurology
• Supplement Type: normal 180 day track
• Supplement Reason: change design/components/specifications - component
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for the precision spectra system which includes the following components: 1) model sc-1132 precision spectra implantable pulse generator (lpg); 2)model sc-440 i precision spectra lpg port plug; 3) model sc-5132 precision spectra external trial stimulator; 4) model sc-6360-32 precision spectra patient trial belt; 4) model sc-6500-32 patient trial kit; 5) model sc-5232 precision spectra remote control; 6) model sc-5532-1 precision spectra remote control kit; 7) model nm-631 0 and nm-621 0 usb power supply; and 8) model nm-621 0 remote control holster. The device, as modified, will be marketed under the trade name precision spectra system and is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.