|
Device | Precision 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 | S286 |
Date Received | 02/28/2017 |
Decision Date | 03/28/2017 |
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 Alternate QC Final Acceptance Sampling Methodology -Acceptable Quality Limit (AQL) instead of the existing LTPD sampling method. |