This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
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.
| Device | RESQCPR SYSTEM |
| Generic Name | Combination Compression/decompression Manual Chest Pump With Impedance Respiratory Valve |
| Applicant | ADVANCED CIRCULATORY SYSTEMS, INC. |
| Date Received | 2011-06-15 |
| Decision Date | 2015-03-06 |
| Notice Date | 2015-03-19 |
| PMA | P110024 |
| Supplement | S |
| Product Code | PIZ |
| Docket Number | 15M-0738 |
| Advisory Committee | Cardiovascular |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | ADVANCED CIRCULATORY SYSTEMS, INC. 1905 County Road C West roseville, MN 55113 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110024 | Original Filing | |
| S003 | 2021-08-25 | Real-time Process |
| S002 | ||
| S001 | 2015-05-12 | Real-time Process |