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 -Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage |
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 | S323 |
Date Received | 02/12/2019 |
Decision Date | 05/14/2019 |
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 to activate the on-board Bluetooth (BLE) functionality of your Freelink RC4 remote control device. The activation of the BLE is for data transmission from the Freelink RC4 to an application on a non-medical mobile device for the purpose of data logging. |
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