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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceResQCPR System
Generic NameCombination compression/decompression manual chest pump with impedance respiratory valve
ApplicantZOLL Medical Corporation
269 Mill Rd.
Chelsmford, MA 01824
PMA NumberP110024
Supplement NumberS003
Date Received08/25/2021
Decision Date11/17/2021
Product Code PIZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a texture on the sealing surface of the ResQPOD ITD 16 diaphragm, a component of the ResQCPR System.
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