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. |
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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 | S003 |
Date Received | 08/08/1990 |
Decision Date | 04/18/1991 |
Product Code |
LSX |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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