|
Device | Precision Montage MRI Spinal Cord Stimulator (SCS)System; Precision Montage Spinal Cord Stimulator (SCS)System; Precisio |
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 | S285 |
Date Received | 02/27/2017 |
Decision Date | 03/24/2017 |
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 Updating the test equipment software (remove certain tests) used for testing the Printed Circuit Board Assembly (PCBA) of the Remote Control (RC) of the Precision Montage MRI, Precision Montage, Precision Spectra and Precision Novi Systems. |