Approval of the lifeline/reviver ddu-100, lifeline/reviver auto ddu-120, lifeline/reviver view ddu-2300, lifeline/reviver view auto ddu-2200, lifeline/reviver ecg ddu-2450, and lifeline/reviver ecg+ ddu-2475 automated external defibrillators. The lifeline/reviver ddu-100 series automated external defibrillator (aed) is indicated for use on victims of sudden cardiac arrest (sca) who are:1) unconscious and unresponsive; and2) not breathing or not breathing normally. Lifeline/reviver ddu-100 series aeds may be used with defibtech adult defibrillation pads (model number ddp-100). For patients under 8 years old, or weighing less than 55 lbs (25 kg), use defibtech child/infant defibrillation pads (model number ddp-200p), if available. The lifeline/reviver ddu-2000 series automated external defibrillator (aed) is indicated for use on victims of sudden cardiac arrest (sca) who are:1) unconscious and unresponsive; and2) not breathing or not breathing normally. Lifeline/reviver ddu-2000 series aeds may be used with defibtech adult defibrillation pads (model number ddp-2001). For patients under 8 years old, or weighing less than 55 lbs (25 kg), use defibtech child/infant defibrillation pads (model number ddp-2002), if available.
| Device | Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU- |
| Classification Name | Automated External Defibrillators (non-wearable) |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | DEFIBTECH, LLC |
| Date Received | 2016-08-02 |
| Decision Date | 2018-02-01 |
| Notice Date | 2018-05-14 |
| PMA | P160032 |
| Supplement | S |
| Product Code | MKJ |
| Docket Number | 18M-0528 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEFIBTECH, LLC 741 Boston Post Road suite 201 guilford, CT 06437 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160032 | | Original Filing |
| S010 |
2021-06-14 |
Real-time Process |
| S009 |
2020-07-27 |
Real-time Process |
| S008 |
2020-07-21 |
Real-time Process |
| S007 |
2020-05-26 |
30-day Notice |
| S006 |
2020-05-08 |
30-day Notice |
| S005 | | |
| S004 |
2020-01-27 |
Real-time Process |
| S003 | | |
| S002 | | |
| S001 |
2018-11-09 |
30-day Notice |
NIH GUDID Devices