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 | AMPLATZER PFO Occluder |
Generic Name | Transcatheter septal occluder |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P120021 |
Supplement Number | S010 |
Date Received | 02/15/2019 |
Decision Date | 03/05/2019 |
Product Code |
MLV |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternate sterilization site located at Sterigenics, 5725 Harold Gatty Drive, Salt Lake City, Utah. |
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