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 Spectra, Spectra WaveWriter, Precision Novi, Precision Montage, Precision Montage, MRI Spinal Cord Stimulator |
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 | S301 |
Date Received | 08/03/2017 |
Decision Date | 08/31/2017 |
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 Automated overmolding process for the header assembly of the Implantable Pulse Generators (IPG) of the Precision Spectra System, Spectra WaveWriter System, Precision Novi System, Precision Montage and Precision Montage MRI Systems. |
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