|
Device | Harmony™ Transcatheter Pulmonary Valve |
Generic Name | Pulmonary valve prosthesis percutaneously delivered |
Applicant | Medtronic, Inc. 3576 Unocal Place Building A Santa Rosa, CA 95403 |
PMA Number | P200046 |
Supplement Number | S011 |
Date Received | 07/26/2022 |
Decision Date | 07/27/2022 |
Product Code |
NPV |
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 Increase in the timeframe for receipt of porcine pericardial tissue from abattoirs and initiation of tissue fixation. |