|
Device | PRESCISION SPINAL CORD STIMULATOR SYSTEM (SCS) |
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 | S116 |
Date Received | 03/01/2011 |
Decision Date | 03/28/2011 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement ADDITION OF AN ALTERNATE ASSEMBLY METHOD FOR THE LEADS AND EXTENSIONS FOR THE PRECISION® SPINAL CORD STIMULATOR (SCS) SYSTEM. |