TITRATOR MODEL 10K

Controller, Closed-loop, Blood-pressure

FDA Premarket Approval P860035

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceTITRATOR MODEL 10K
Classification NameController, Closed-loop, Blood-pressure
Generic NameController, Closed-loop, Blood-pressure
ApplicantIVAC CORPORATION
Date Received1986-08-21
Decision Date1987-12-17
Notice Date1988-02-10
PMAP860035
SupplementS
Product CodeLSX
Docket Number88M-0005
Advisory CommitteeGeneral Hospital
Expedited ReviewNo
Combination Product No
Applicant Address IVAC CORPORATION 10300 Campus Point Dr. san Diego, CA 92121

Supplemental Filings

Supplement NumberDateSupplement Type
P860035Original Filing
S005 1992-03-25 Normal 180 Day Track
S004 1990-09-20 Normal 180 Day Track
S003 1990-08-08 Normal 180 Day Track
S002 1990-05-22 Normal 180 Day Track
S001 1989-03-15 Normal 180 Day Track

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