|
Device | Harmony™ Delivery Catheter System |
Generic Name | Pulmonary valve prosthesis percutaneously delivered |
Applicant | Medtronic, Inc. 3576 Unocal Place Building A Santa Rosa, CA 95403 |
PMA Number | P200046 |
Supplement Number | S012 |
Date Received | 10/31/2022 |
Decision Date | 11/01/2022 |
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 Automation of a verification step undertaken by Sterile Release Personnel (SRP) for Limulus amebocyte lysate (LAL) Bacterial Endotoxin Testing (BET) prior to final release of product. |