Approval for a new warning associated with premature battery depletion of the lifepak cr2 lithium battery.
| Device | LIFEPAK CR2 Automated External Defibrillator |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | Physio-Control, Inc |
| Date Received | 2021-01-25 |
| Decision Date | 2021-02-16 |
| PMA | P170018 |
| Supplement | S012 |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Physio-Control, Inc 11811 Willows Road Ne redmond, WA 98052 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P170018 | | Original Filing |
| S015 |
2022-10-13 |
Real-time Process |
| S014 |
2022-07-27 |
Real-time Process |
| S013 |
2021-05-17 |
30-day Notice |
| S012 |
2021-01-25 |
Special (immediate Track) |
| S011 |
2020-10-02 |
30-day Notice |
| S010 |
2020-09-11 |
30-day Notice |
| S009 |
2020-09-10 |
30-day Notice |
| S008 |
2020-08-26 |
30-day Notice |
| S007 |
2020-06-12 |
Real-time Process |
| S006 |
2020-04-23 |
30-day Notice |
| S005 | | |
| S004 |
2019-09-11 |
Real-time Process |
| S003 |
2019-01-15 |
Real-time Process |
| S002 |
2019-01-11 |
Real-time Process |
| S001 |
2018-12-31 |
30-day Notice |
NIH GUDID Devices