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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.
 
DevicePrecision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Precision Spectra WaveWriter
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp.
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS317
Date Received07/03/2018
Decision Date08/02/2018
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Addition of Guidant Puerto Rico B.V. as an alternate qualified manufacturing site for the laser ablation of multi-lumen tubes used in the assembly of the following leads for the Precision®, Precision Spectra, Precision NoviTM, Precision Montage, Precision MontageTM MRI and Precision Spectra WaveWriter Spinal Cord Stimulator (SCS) Systems: Linear Leads, Linear ST Leads, Linear 3-4 Leads, Linear 3-6 Leads, Lead Extensions, M8 & S8 Adapters, Artisan Surgical Leads, Artisan MRI Surgical Leads, CovcrEdge Surgical Leads, CoverEdge X Surgical Leads, Infinion and lnfinion CX 16 Contact Leads.
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