|
Device | PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS |
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 | S156 |
Date Received | 02/20/2013 |
Decision Date | 05/08/2013 |
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 A COLORANT CHANGE TO THE HUB PORTION OF THE INTRODUCER, ASURGICAL ACCESSORY FOR THE PRECISION SPINAL CORD STIMULATION SYSTEM THAT IS USED TO FACILITATE PLACEMENT OF A LEAD INTO THE EPIDURAL SPACE. |