Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device. |
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Trade Name | SHELHIGH NO-REACT PORCINE PULMONIC VALVE CONDUIT |
Classification Name | replacement heart-valve |
Generic Name | replacement heart-valve |
Regulation Number | 870.3925 |
Applicant |
SHELHIGH, INC. |
650 liberty ave. |
union, NJ 07083 |
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HDE Number | H980007 |
Supplement Number | S002 |
Date Received | 12/09/2002 |
Decision Date | 11/24/2003 |
Product Code | |
Docket Number | 99M-4810 |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to amend the product labeling to allow patients up to 10 years of age to receive the device and to make the device available in sizes up to a 23mm valve. The device is now indicated for replacement of diseased, damaged or absent pulmonic artery in infants or small children up to age 10 years, with transposition of the great arteries, tnincus arteriosis, tetrology of fallot with associated cardiac anomalies or with pulmonary atresia, or replacement of failed conduits in young patients with accelerated conduit failure. |
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