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 | LLESTO 7 VR-T, IFORIA 7 VR-T, LLESTO 5 VR-T, IFORIA 5 VR-T, LUMAX 740 VR-T, LLESTO 7 DR-T, IFORIA 7 DR-T, LLESTO 5 DR-T |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P050023 |
Supplement Number | S080 |
Date Received | 09/24/2014 |
Decision Date | 10/21/2014 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement CHANGE TO THE LABELING SOFTWARE WHICH IS USED TO PRINT LABELS FOR THE DEVICES. |
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