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 |