Note: 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. |
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Device | LIFEPAK® 35 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 | S040 |
Date Received | 07/18/2023 |
Decision Date | 04/12/2024 |
Product Code |
MKJ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new model of professional-use automated external defibrillator (AED), the LIFEPAK 35 Monitor/Defibrillator, the LIFEPAK Therapy Cable, LIFEPAK FLEX Lithium-Ion Battery and a Predetermined Change Control Plan (PCCP), dated April 10, 2024, for noninvasive blood pressure modules and cleaning modifications. |
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