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) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM |
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 | S157 |
Date Received | 03/04/2013 |
Decision Date | 05/30/2013 |
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 AN UPDATING TO THE CLINICIAN PROGRAMMER COMPUTER USED WITH THE PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS. A TABLET COMPUTER FROM ASUS, MODEL EEE SLATE B121, WILL BE USED TO REPLACE THE CURRENT CLINICIAN PROGRAMMER, A TOSHIBA MODEL M400 LAPTOP COMPUTER. THE ASUS TABLET IS AN OFF-THE-SHELF COMPUTER, CUSTOMIZED TO BE A CLINICIANS PROGRAMMER BY INSTALLING THE EEE SLATE B121 BOOT AND IMAGE SOFTWARE AND CONFIGURING THE SYSTEM WITH THE BN1.2 AND BN3 BIONICNAVIGATOR SOFTWARE. |
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