Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
|
Trade Name | SHELHIGH NO-REACT PORCINE PULMONIC VALVE CONDUIT |
Classification Name | pulmonic replacement heart valve |
Generic Name | pulmonic replacement heart valve |
Regulation Number | 870.3925 |
Applicant |
SHELHIGH, INC. |
650 liberty ave. |
union, NJ 07083 |
|
HDE Number | H980007 |
Date Received | 10/20/1998 |
Decision Date | 09/30/1999 |
Product Code | |
Docket Number | 99M-4810 |
Advisory Committee |
Cardiovascular |
Supplement Type | hde original |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement For replacement of the diseased, damaged, or absent pulmonic artery in small children or infants up to age 4 years, with transposition of the great arteries, truncus arteriosis, tetrology of fallot with associated cardiac anomalies or with pulmonary atresia, or replacement of failed conduits in young patients with accelereated conduit failure. |
Approval Order | Approval Order |
Summary | Summary of Safety And Probable Benefit |
Labeling | Labeling
|
Supplements: |
S001 S002 |
|
|