|
Device | X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM |
Generic Name | Prosthesis, spinous process spacer/plate |
Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P040001 |
Supplement Number | S012 |
Date Received | 02/09/2009 |
Decision Date | 01/28/2010 |
Withdrawal Date
|
04/30/2015 |
Product Code |
NQO |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A LABELING CHANGE TO ADD PLACEMENT OF THE PATIENT IN THE PRONE POSITION DURING IMPLANTATION OF THE DEVICE. |
Post-Approval Study | Show Report Schedule and Study Progress |