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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 | S009 |
Date Received | 08/07/2012 |
Decision Date | 08/29/2012 |
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 modifications to the sterilization labeling and is indicated fro the treatment of thoracic insufficiency syndrome (tis) in skeletally immature patients. Tis is defined as the inability of the thorax to support normal respiration or lung growth. For the purpose of identifying potential tis patients, the categories in which tis patients fall are as follows: flail chest syndrome, constrictive chest wall syndrome including rib fusion and scoliosis. Hypoplastic thorax syndrome including jeune's syndrome. Anchondroplasia, jarcho-levin syndrome, ellis van creveld syndrome and progressive scoliosis of congenital or neurogenic origin without rib anomaly. |