|
Device | LIFEPAK® 15 monitor/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 | P160026 |
Supplement Number | S043 |
Date Received | 09/28/2023 |
Decision Date | 10/18/2023 |
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 leaving the LIFEPAK 15 device powered on for an extended amount of time. Additionally, an existing warning associated with the AED Mode will be updated to include clarifying information. |