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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namecombination compression/decompression manual chest pump with impedance respiratory valve
PMA NumberP110024
Date Received06/15/2011
Decision Date03/06/2015
Product Code
Docket Number 15M-0738
Notice Date 03/19/2015
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the resqcpr system. This device is indicated for use as a cpr adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest.
Approval Order Approval Order
Supplements: S001