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. |
|
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 | S009 |
Date Received | 08/28/2017 |
Decision Date | 02/22/2018 |
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 a manufacturing site located at Apex Tools & Orthopedics Company, 22 Xinzhuang Road 2,Yonghe, GETDD, Guangzhou 511356, China for manufacture of surgical instrumentation. |
|
|