|
Device | PRECISION 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 | S152 |
Date Received | 01/28/2013 |
Decision Date | 08/26/2014 |
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 ADDITION OF THE COVEREDGE 4X8 SURGICAL LEAD (ALSO REFERRED TO AS THE 32 CONTACT PADDLE LEAD) AND PADDLE BLANKS TO BE USED WITH THE PRECISION SPECTRA SPINAL CORD STIMULATION SYSTEM. |