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 manufacturing site at nellcor puritan bennett, 2200 faraday ave. , carlsbad, ca.
| Device | HIGH FREQUENCY VENTILATOR |
| Generic Name | Ventilator, High Frequency |
| Applicant | NELLCOR PURITAN BENNETT, INC. |
| Date Received | 1996-10-11 |
| Decision Date | 1997-06-24 |
| PMA | P880013 |
| Supplement | S007 |
| Product Code | LSZ |
| Advisory Committee | Anesthesiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NELLCOR PURITAN BENNETT, INC. 2200 Faraday Ave. carlsbad, CA 92008-7208 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880013 | Original Filing | |
| S009 | 2002-04-22 | Normal 180 Day Track |
| S008 | 1998-03-30 | 30-day Notice |
| S007 | 1996-10-11 | Normal 180 Day Track |
| S006 | ||
| S005 | ||
| S004 | ||
| S003 | 1993-09-21 | Normal 180 Day Track |
| S002 | 1992-04-10 | Normal 180 Day Track |
| S001 | 1992-03-23 | Normal 180 Day Track |