|
Trade Name | Contegra Pulmonary Valved Conduit, Models 200 and 200s |
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 | S032 |
Date Received | 07/10/2017 |
Decision Date | 08/09/2017 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Implement additional test samples for solution chemistry and sterility as part of the routine monitoring and lot release performed for terminal liquid sterilization. |