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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePrecisionTM and Spectra WaveWriterTM Spinal Cord Stimulation (SCS) Systems
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Namestimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp.
25155 rye canyon loop
valencia, CA 91355
PMA NumberP030017
Supplement NumberS275
Date Received12/27/2016
Decision Date08/11/2017
Product Code
LGW[ Registered Establishments with LGW ]
Docket Number 17M-4904
Notice Date 10/23/2017
Advisory Committee Neurology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for expanding indications to include Complex Regional Pain Syndrome (CRPS) Types I and II and the following associated conditions and etiologies: radicular pain syndrome, radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, epidural fibrosis, degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions), arachnoiditis, and multiple back surgeries.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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