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.
Approval of the protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p160015.
|Device||AED 3 Defibrillator with Uni-Padz|
|Generic Name||Automated External Defibrillators (non-wearable)|
|Applicant||ZOLL MEDICAL CORPORATION|
|Supplement Type||Normal 180 Day Track No User Fee|
|Supplement Reason||Postapproval Study Protocol - Ode/oir|
|Applicant Address||ZOLL MEDICAL CORPORATION 269 & 271 Mill Road chelmsford, MA 01824|
|Supplement Number||Date||Supplement Type|
|S004||2020-03-27||Normal 180 Day Track No User Fee|
|S002||2018-08-23||135 Review Track For 30-day Notice|