Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Aveir DR Leadless System |
Generic Name | Leadless pacemaker |
Regulation Number | 870.3610 |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91342 |
PMA Number | P150035 |
Supplement Number | S003 |
Date Received | 01/17/2023 |
Decision Date | 06/29/2023 |
Product Code |
PNJ |
Docket Number | 23M-3561 |
Notice Date | 09/07/2023 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT05252702
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Supplement Type | Panel Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the Aveir DR Leadless System, Aveir Leadless Pacemaker (Right Ventricular), Aveir Leadless Pacemaker (Right Atrial), Aveir Delivery Catheter, Aveir Link Module. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
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