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 | COLLAGRAFT STRIP BONE GRAFT MATRIX |
Generic Name | Filler, bone void, non-osteoinduction |
Applicant | NEUCOLL, INC. 105 COOPER CT. LOS GATOS, CA 95032-7604 |
PMA Number | P900039 |
Supplement Number | S011 |
Date Received | 09/19/2001 |
Decision Date | 07/02/2002 |
Reclassified Date
|
06/02/2003 |
Product Code |
MBS |
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 ADDITION MANUFACTURING SITES LOCATED AT: BIOSERV CORPORATION, SAN DIEGO, CALIFORNIA; BIOLOGICAL TEST CENTER, B. BRAUN MEDICAL, INC., IRVINE, CALIFORNIA; NEUCOLL, INC., CAMBELL, CALIFORNIA; AND PHARMACEUTICAL SYSTEMS, INC., MUNDALEIN, ILLINOIS. |
|
|