|
Device | PRECISION MONTAGE MRI AND 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 | S265 |
Date Received | 10/31/2016 |
Decision Date | 11/24/2016 |
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 Changes to the test equipment and associated software used for Continuity and HiPot testing of your Avista MRI Leads. |