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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceLIFE PULSE HIGH FREQUENCY VENTILATOR
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantBunnell, Inc.
436 Lawndale Dr.
Salt Lake City, UT 84115
PMA NumberP850064
Supplement NumberS016
Date Received09/10/1999
Decision Date10/05/1999
Product Code LSZ 
Advisory Committee Anesthesiology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of three warnings.
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