|
Trade Name | OP-1 IMPLANT |
Classification Name | filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction |
Generic Name | filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction |
Applicant |
OLYMPUS BIOTECH CORPORATION |
35 south st |
hopkinton, MA 01748 |
|
HDE Number | H010002 |
Supplement Number | S007 |
Date Received | 05/02/2003 |
Decision Date | 07/10/2003 |
Product Code | |
Docket Number | 01M-0482 |
Advisory Committee |
Orthopedic |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes in labeling and patient brochure. |