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.
| Device | LIFEPAK® CR2 Defibrillator |
| Generic Name | Automated External Defibrillators (non-wearable) |
| Applicant | Physio-Control, Inc11811 Willows Road Neredmond, WA 98052 PMA NumberP170018 Supplement NumberS015 Date Received10/13/2022 Decision Date01/10/2023 Product Code MKJ Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-10-13 |
| Decision Date | 2023-01-10 |
| PMA | P170018 |
| Supplement | S015 |
| Product Code | MKJ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Physio-Control, Inc 11811 Willows Road Ne redmond, WA 98052 PMA NumberP170018 Supplement NumberS015 Date Received10/13/2022 Decision Date01/10/2023 Product Code MKJ Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Adding A Clip Over The Magnetic Component In The LIFEPAK CR2 Defibrillator Lid. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00883873867808 | P170018 | 000 |
| 00883873871577 | P170018 | 000 |
| 00883873790687 | P170018 | 000 |
| 00883873824061 | P170018 | 002 |
| 00883873824078 | P170018 | 002 |
| 00883873824085 | P170018 | 002 |
| 00883873824092 | P170018 | 002 |
| 00883873824108 | P170018 | 002 |
| 00883873824115 | P170018 | 002 |
| 00883873824122 | P170018 | 002 |
| 00883873824139 | P170018 | 002 |