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 | Lifeline/ReviveR, Lifeline/ReviveR AUTO, Lifeline/ReviveR VIEW, Lifeline/ReviveR VIEW AUTO, Lifeline/ReviveR ECG, and Li |
Generic Name | Automated external defibrillators (non-wearable) |
Regulation Number | 870.5310 |
Applicant | DEFIBTECH, LLC 741 BOSTON POST ROAD Suite 201 GUILFORD, CT 06437 |
PMA Number | P160032 |
Supplement Number | S006 |
Date Received | 05/08/2020 |
Decision Date | 06/04/2020 |
Product Code |
MKJ |
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 a thermal conditioning and screening process step during DDU-100 and DDU-2000 manufacturing. |
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