|
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 | S026 |
Date Received | 08/08/2007 |
Decision Date | 06/23/2008 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE IPG RESISTANCE WELDING PROCESS OF THE ANTENNA WIRE. |