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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NamePRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP030017
Supplement NumberS134
Date Received05/07/2012
Decision Date12/21/2012
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typenormal 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.
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