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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.
 
DeviceELECTROMECHANICAL ENHANCEMENT TO DRIVER
Generic NameVENTILATOR, HIGH FREQUENCY
ApplicantZOLL Medical Corporation
269 Mill Rd.
Chelsmford, MA 01824
PMA NumberP890057
Supplement NumberS013
Date Received11/19/1999
Decision Date04/11/2000
Product Code LSZ 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a modified 3.0 ohms drivers coil assembly.
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