|
Device | PRECISION SPECTRA 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 | S259 |
Date Received | 09/09/2016 |
Decision Date | 10/06/2016 |
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 Use of an alternate bonding method during the manufacture of the charging coil, an electronic component on the Printed Circuit Board Assembly (PCBA) of the Precision Spectra Implantable Pulse Generator (IPG). |