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 | X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™ |
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 | S010 |
Date Received | 04/08/2019 |
Decision Date | 07/03/2019 |
Product Code |
MKJ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for hardware and software changes to achieve compliance with an FDA-recognized consensus standard for electromagnetic compatibility. |
|
|