Premarket Approval (PMA)

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.

• Device: TITRATOR{TM} MODEL 10K
• Generic Name: CONTROLLER, CLOSED-LOOP, BLOOD-PRESSURE
• Applicant: IVAC CORPORATION; 10300 CAMPUS POINT DR.; SAN DIEGO, CA 92121
• PMA Number: P860035
• Supplement Number: S004
• Date Received: 09/20/1990
• Decision Date: 12/28/1990
• Product Code: LSX
• Advisory Committee: General Hospital
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No