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. |
|
Device | AED Pro Device |
Generic Name | Automated external defibrillators (non-wearable) |
Regulation Number | 870.5310 |
Applicant | ZOLL MEDICAL CORPORATION 269 & 271 MILL ROAD CHELMSFORD, MA 01824-4105 |
PMA Number | P160022 |
Supplement Number | S012 |
Date Received | 07/26/2019 |
Decision Date | 08/22/2019 |
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 conformal coating and hipot test to the analog board, and updates to the system level testing. |
|
|