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 | LifePulse High Frequency Ventilator |
Generic Name | VENTILATOR, HIGH FREQUENCY |
Applicant | BUNNELL, INC. 436 LAWNDALE DR. SALT LAKE CITY, UT 84115 |
PMA Number | P850064 |
Supplement Number | S053 |
Date Received | 09/29/2023 |
Decision Date | 12/28/2023 |
Product Code |
LSZ |
Advisory Committee |
Anesthesiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for the filter element that is included in the Camozzi Filter Assembly. The filter element, made from HDPE, has gone from a white with pink speckles color to a light blue color. All other specifications remain the same and the color change is being made to differentiate between filter elements. |
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