|
Device | PRECISION SPECTRA 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 | S168 |
Date Received | 05/22/2013 |
Decision Date | 08/06/2013 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE OF THE OUTER BOX USED AS SECONDARY PACKAGINGFOR THE PRECISION SPECTRA IMPLANTED PULSE GENERATOR, AND THE SPECTRA OPERATING ROOM CABLE/EXTENSION KITS. |