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Device | Amplatzer™ Amulet™ Left Atrial Appendage Occluder |
Generic Name | System, appendage closure, left atrial |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P200049 |
Supplement Number | S004 |
Date Received | 06/16/2022 |
Decision Date | 07/28/2022 |
Product Code |
NGV |
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 Addition of alternate laser cutting and welding systems used in the manufacturing of the Amplatzer Amulet Left Atrial Appendage Occluder. |