|
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 | S014 |
Date Received | 03/19/2009 |
Decision Date | 04/16/2009 |
Withdrawal Date
|
04/30/2015 |
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 CHANGE OF ADHESIVE USED IN THE MANUFACTURING PROCESS OF THE DEVICE. |