|
Device | PRECISION 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 | S251 |
Date Received | 03/14/2016 |
Decision Date | 06/07/2016 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for adding an alternate qualified supplier for the Coil Connector that is used in the assembly of the Precision M1 and M8 Adaptors. |