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.
Approval for a texture on the sealing surface of the resqpod itd 16 diaphragm, a component of the resqcpr system
| Device | ResQCPR System |
| Generic Name | Combination Compression/decompression Manual Chest Pump With Impedance Respiratory Valve |
| Applicant | ADVANCED CIRCULATORY SYSTEMS, INC. |
| Date Received | 2021-08-25 |
| Decision Date | 2021-11-17 |
| PMA | P110024 |
| Supplement | S003 |
| Product Code | PIZ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ADVANCED CIRCULATORY SYSTEMS, INC. 1905 County Road C West roseville, MN 55113 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110024 | Original Filing | |
| S003 | 2021-08-25 | Real-time Process |
| S002 | ||
| S001 | 2015-05-12 | Real-time Process |