Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Superion™ Indirect Decompression System (IDS) |
Generic Name | Prosthesis, spinous process spacer/plate |
Applicant | Boston Scientific Neuromodulation 25155 Rye Canyon Loop Valencia, CA 91355 |
PMA Number | P140004 |
Supplement Number | S025 |
Date Received | 07/30/2021 |
Decision Date | 08/26/2021 |
Product Code |
NQO |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Distribute the device incorporating the change as requested in this supplement. This change applies to the final assembly of the Superion Indirect Decompression System (IDS) device. The following manufacturing facility is affected by the change: Boston Scientific Limited, Cashel Rd, ClonmelCo, Tipperary, Ireland. |
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