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Trade Name | VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) |
Classification Name | prosthesis, rib replacement |
Generic Name | prosthesis, rib replacement |
Regulation Number | 888.3070 |
Applicant |
SYNTHES SPINE |
325 paramount drive |
raynham, MA 02767 |
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HDE Number | H030009 |
Supplement Number | S006 |
Date Received | 11/10/2009 |
Decision Date | 01/13/2010 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the veptr ii patient guide. |