|
Device | X-STOP INTERSPINOUS SPACER SYSTEM |
Generic Name | Prosthesis, spinous process spacer/plate |
Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P040001 |
Supplement Number | S020 |
Date Received | 02/29/2012 |
Decision Date | 07/25/2012 |
Withdrawal Date
|
04/30/2015 |
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 MEDTRONIC SOFAMOR DANEK USA, INC. IN MEMPHIS, TENNESSEE. |