|
Device | PRECISION NOVI SPINAL CORD STIMULATION(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 | S264 |
Date Received | 10/25/2016 |
Decision Date | 11/23/2016 |
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 Addition of an alternate qualified supplier for the carbon fluorination process, which is used to produce polycarbon fluoride (CFx) material for use in the primary cell battery of the Precision Novi Implantable Pulse Generator. |