|
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 | S237 |
Date Received | 09/22/2015 |
Decision Date | 10/22/2015 |
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 IMPLEMENTATION OF AN UPDATE TO THE TEST EQUIPMENT SYSTEM AND ASSOCIATED SOFTWARE USED FOR TESTING CONTINUITY AND HIPOT ON THE ARTISAN (2X8) SURGICAL (PADDLE) LEAD AND COVEREDGE 32 CONTACT SURGICAL (PADDLE) LEADS. |