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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.
 
DeviceHFV INFANT STAR VENTILATOR
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantNellcor Puritan Bennett, Inc.
2200 Faraday Ave.
Carlsbad, CA 92008
PMA NumberP880013
Supplement NumberS008
Date Received03/30/1998
Decision Date04/07/1998
Withdrawal Date08/29/2007
Product Code LSZ 
Advisory Committee Anesthesiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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