|
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 | S125 |
Date Received | 12/09/2011 |
Decision Date | 01/04/2012 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement A NEW FABRICATION SITE FOR THE SUPPLIER OF THE ANALOG INTEGRATED CIRCUIT (IC) IN THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) OF THE IMPLANTABLE PULSE GENERATOR (IPG) FOR THE PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM. |