|
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 | S036 |
Date Received | 10/30/2018 |
Decision Date | 02/22/2022 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change in formulation of detergent used in the manufacturing process of the device. |