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 | S001 |
Date Received | 08/28/2000 |
Decision Date | 09/27/2000 |
Product Code | |
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 for modifications in the design of the device, resulting in model numbers nr-4000-m02, and nr-4000-pa. We have also considered model nr-4000ss, which was not described in the original submission. |
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