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. |
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Device | Precision Spinal Cord Stimulator (SCS) Systems |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Boston Scientific Corp. 25155 Rye Canyon Loop Valencia, CA 91355 |
PMA Number | P030017 |
Supplement Number | S337 |
Date Received | 04/20/2020 |
Decision Date | 05/15/2020 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Modification of the Printed Circuit Board Assembly inspections for the Implantable Pulse Generators of the Precision Spectra System, Spectra Wave Writer System, Precision Novi System, Precision Montage and Precision Montage MRI Systems. |
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