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 | LUMBAR I/F CAGE SYSTEM |
Generic Name | SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM |
Applicant | DEPUY SPINE,INC 325 PARAMONT DRIVE RAYNHAM, MA 02767 |
PMA Number | P960025 |
Supplement Number | S007 |
Date Received | 05/17/2001 |
Decision Date | 09/17/2001 |
Reclassified Date
|
07/12/2007 |
Product Code |
MCV |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT DEPUY ACROMED, RAYNHAM, MASSACHUSETTS. |
|
|