|
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 |
|
HDE Number | H020003 |
Supplement Number | S039 |
Date Received | 09/26/2019 |
Decision Date | 12/10/2019 |
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 a modification to the polypropylene resin material formulation used in the packaging lid and retainer assembly. |