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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR
Classification Nameventilator, high frequency
Generic Namehigh frequency ventilator
ApplicantCOVIDIEN
PMA NumberP890034
Supplement NumberS006
Date Received10/15/1996
Decision Date06/24/1997
Product Code
LSZ[ Registered Establishments with LSZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing facility at nellcor puritan bennett, 2200 faraday ave. , carlsbad, ca.
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