|
Device | X-STOP PEEK INTERSPINOUS PROCESS DECOMPRESSION SYSTEM/ 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 | S022 |
Date Received | 08/26/2014 |
Decision Date | 10/24/2014 |
Withdrawal Date
|
04/30/2015 |
Product Code |
NQO |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |
Post-Approval Study | Show Report Schedule and Study Progress |