|
Device | PRECISION SPECTRA AND PRECISION NOVI 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 | S240 |
Date Received | 10/26/2015 |
Decision Date | 11/24/2015 |
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 USE OF AN UPDATED TEST EQUIPMENT SYSTEM USED FOR TESTING THE PRECISION SPECTRA REMOTE CONTROL USED TO SUPPORT THE PRECISION SPECTRA IPG AND THE FREELINK REMOTE CONTROL USED TO SUPPORT BOTH PRECISION SPECTRA AND PRECISION NOVI IPGS. |