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 | AngelMed Guardian System |
Generic Name | Acute coronary syndrome event detector |
Applicant | Avertix Medical Inc 40 Christopher Way Suite 201 Eatontown, NJ 07724 |
PMA Number | P150009 |
Supplement Number | S004 |
Date Received | 12/01/2020 |
Decision Date | 12/22/2020 |
Product Code |
QBI |
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 component change the implantable and external device components of the AngelMed Guardian System |
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