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 a new manufacturing facility at nellcor puritan bennett, 2200 faraday ave. , carlsbad, ca.
| Device | MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR |
| Generic Name | Ventilator, High Frequency |
| Applicant | Covidien |
| Date Received | 1996-10-15 |
| Decision Date | 1997-06-24 |
| PMA | P890034 |
| Supplement | S006 |
| Product Code | LSZ |
| Advisory Committee | Anesthesiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |