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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.
 
Device3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantZOLL Medical Corporation
269 Mill Rd.
Chelsmford, MA 01824
PMA NumberP890057
Supplement NumberS022
Date Received04/29/2014
Decision Date06/02/2014
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
Approval Order Statement  
CHANGE TO THE DIAPHRAGM CAP ASSEMBLY.
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