ResQCPR System

FDA Premarket Approval P110024 S003

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.

Pre-market Approval Supplement Details

Approval for a texture on the sealing surface of the resqpod itd 16 diaphragm, a component of the resqcpr system

DeviceResQCPR System
Generic NameCombination Compression/decompression Manual Chest Pump With Impedance Respiratory Valve
ApplicantADVANCED CIRCULATORY SYSTEMS, INC.
Date Received2021-08-25
Decision Date2021-11-17
PMAP110024
SupplementS003
Product CodePIZ 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED CIRCULATORY SYSTEMS, INC. 1905 County Road C West roseville, MN 55113

Supplemental Filings

Supplement NumberDateSupplement Type
P110024Original Filing
S003 2021-08-25 Real-time Process
S002
S001 2015-05-12 Real-time Process

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