|
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 | S132 |
Date Received | 04/12/2012 |
Decision Date | 05/10/2012 |
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 USE AN ALTERNATIVE OVEN DURING THE MANUFACTURE OF W4 AND D4 2X4 SPLITTERS FOR THE DEVICE. |