|
Device | PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM IPG/ETS 3.0 |
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 | S012 |
Date Received | 03/22/2006 |
Decision Date | 05/12/2006 |
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 THE IMPLANTED PULSE GENERATOR (IPG)/EXTERNAL TRIAL STIMULATOR (ETS) FIRMWARE VERSION 3.0. |