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 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170018 | Original Filing | |
| 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 |