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Device | LIFEPAK CR2 Automated External Defibrillator |
Generic Name | Automated external defibrillators (non-wearable) |
Regulation Number | 870.5310 |
Applicant | Physio-Control, Inc 11811 Willows Road NE Redmond, WA 98052 |
PMA Number | P170018 |
Supplement Number | S012 |
Date Received | 01/25/2021 |
Decision Date | 02/16/2021 |
Product Code |
MKJ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new warning associated with premature battery depletion of the LIFEPAK CR2 lithium battery. |