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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.
 
DeviceTITRATOR{TM} MODEL 10K
Generic NameCONTROLLER, CLOSED-LOOP, BLOOD-PRESSURE
ApplicantIvac Corporation
10300 Campus Pt. Dr.
San Diego, CA 92121
PMA NumberP860035
Supplement NumberS004
Date Received09/20/1990
Decision Date12/28/1990
Product Code LSX 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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