|
Device | PRECISION AND 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 | S191 |
Date Received | 03/14/2014 |
Decision Date | 06/17/2014 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE INFINION CX 16 CONTACT LEAD KIT (MODEL SC-2317-XX) AND ENTRADA NEEDLE (MODEL SC-4220). |