|
Device | Superion Indirect Decompression System |
Generic Name | Prosthesis, spinous process spacer/plate |
Applicant | Boston Scientific Neuromodulation 25155 Rye Canyon Loop Valencia, CA 91355 |
PMA Number | P140004 |
Supplement Number | S024 |
Date Received | 08/24/2020 |
Decision Date | 09/15/2020 |
Product Code |
NQO |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternate manufacturing site named Boston Scientific Limited located at Cashel Road, Clonmel, Ireland for sterile packaging and final packaging. |