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 | X Series, R Series, Propaq MD, and AED Pro |
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 | S027 |
Date Received | 03/15/2021 |
Decision Date | 03/26/2021 |
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 Introduction of a new Automatic Optical Inspection (AOI) machine used during PCBA manufacturing at the supplier. |
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