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Trade Name | CONTEGRA PULMONARY VALVED CONDUIT |
Classification Name | pulmonic valved conduit |
Generic Name | pulmonic valved conduit |
Applicant |
Medtronic, Inc. |
1851 e. deere ave. |
santa ana, CA 92705 |
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HDE Number | H020003 |
Supplement Number | S021 |
Date Received | 05/08/2013 |
Decision Date | 07/12/2013 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for a design change to the primary packaging of the melody transcatheter pulmonary valve (model pbi 0) and the contegra pulmonary valvedconduit (model 200 and 200s). |