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 |
| Classification Name | Controller, Closed-loop, Blood-pressure |
| Generic Name | Controller, Closed-loop, Blood-pressure |
| Applicant | IVAC CORPORATION |
| Date Received | 1989-03-15 |
| Decision Date | 1989-05-01 |
| PMA | P860035 |
| Supplement | S001 |
| Product Code | LSX |
| Advisory Committee | General Hospital |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | IVAC CORPORATION 10300 Campus Point Dr. san Diego, CA 92121 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860035 | Original 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 |