|
Device | PRECISION SPINAL CORD STIMULATION (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 | S144 |
Date Received | 09/20/2012 |
Decision Date | 11/16/2012 |
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 MATERIAL CHANGE FOR THE IMPLANTABLE PULSE GENERATOR (IPG) ANTENNA COIL FROM GOLD TO COPPER. |