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.
Change in the manufacturing site for the fetal sensor emitter, a component of the oxifirst fetal sensor. The sensor emitter will be manufactured at the tyco facility in insurgentes, tijuana, mexico, where the fetal sensors are manufactured.
| Device | OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM |
| Classification Name | Oximeter, Fetal Pulse |
| Generic Name | Oximeter, Fetal Pulse |
| Applicant | Covidien, LLC |
| Date Received | 2002-04-05 |
| Decision Date | 2002-04-18 |
| PMA | P990053 |
| Supplement | S007 |
| Product Code | MMA |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process 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 |