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 located at nellcor puritan bennett, inc. , minneapolis, minnesota. Factory service operations for the n-400 fetal oxygen saturation monitors will be performed at this facility.
| Device | OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM |
| Classification Name | Oximeter, Fetal Pulse |
| Generic Name | Oximeter, Fetal Pulse |
| Applicant | Covidien, LLC |
| Date Received | 2002-04-16 |
| Decision Date | 2002-11-25 |
| PMA | P990053 |
| Supplement | S008 |
| Product Code | MMA |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Covidien, LLC 6135 Gunbarrel Avenue boulder, CO 80301 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990053 | Original Filing | |
| S012 | 2005-03-04 | 135 Review Track For 30-day Notice |
| S011 | 2004-11-22 | 135 Review Track For 30-day Notice |
| S010 | 2002-10-17 | Special (immediate Track) |
| S009 | 2002-04-17 | Normal 180 Day Track |
| S008 | 2002-04-16 | Normal 180 Day Track |
| S007 | 2002-04-05 | 30-day Notice |
| S006 | 2002-03-26 | Normal 180 Day Track |
| S005 | 2001-12-31 | Normal 180 Day Track |
| S004 | ||
| S003 | 2001-10-12 | 30-day Notice |
| S002 | 2001-06-05 | Normal 180 Day Track |
| S001 | 2001-04-09 | Normal 180 Day Track |