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 System, Precision spectra Spinal cord Stimulator System, Spectra WaveWriter Spinal cord |
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 | S314 |
Date Received | 03/28/2018 |
Decision Date | 06/25/2018 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for increasing the inner diameter for the receptacle components of the adapter, and including an alternate qualified supplier for the coil connector with the increased inner diameter. |
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