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 additional manufacturing facility located at nellcor puritan bennett, inc. , minneapolis, minnesota.
| Device | NELLCOR PURITAN BENNETT INFANT STAR HIGH FREQUENCY VENTILATOR |
| Generic Name | Ventilator, High Frequency |
| Applicant | NELLCOR PURITAN BENNETT, INC. |
| Date Received | 2002-04-22 |
| Decision Date | 2002-12-17 |
| PMA | P880013 |
| Supplement | S009 |
| Product Code | LSZ |
| Advisory Committee | Anesthesiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Express Gmp Supplement |
| 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 |