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.
Approval for an proximal monitoring endotracheal tube adapter for use with the adult star model 1010 ultrahigh frequency ventilator - the proximal monitoring adapter will be marketed under the new trade name as the "proximal monitoring adapter"
| Device | MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR |
| Generic Name | Ventilator, High Frequency |
| Applicant | Covidien |
| Date Received | 1995-06-12 |
| Decision Date | 1995-12-28 |
| PMA | P890034 |
| Supplement | S005 |
| Product Code | LSZ |
| Advisory Committee | Anesthesiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Covidien 6135 Gunbarrel Ave. boulder, CO 80301 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890034 | Original Filing | |
| S006 | 1996-10-15 | Normal 180 Day Track |
| S005 | 1995-06-12 | Normal 180 Day Track |
| S004 | 1993-10-22 | Normal 180 Day Track |
| S003 | 1993-12-02 | Normal 180 Day Track |
| S002 | 1993-11-08 | Normal 180 Day Track |
| S001 | 1993-08-12 | Normal 180 Day Track |