|
Device | PRECISION SPINAL CORD STIMULATOR 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 | S088 |
Date Received | 11/03/2008 |
Decision Date | 03/20/2009 |
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 A CHANGE IN THE MANUFACTURING PROCESS OF THE 50 (SC-8216-50) AND 70 CM (SC-8216-70) ARTISAN 2X8 SURGICAL ELECTRODE LEADS. |