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 alternate manufacturing facility located at tyco healthcare group, tijuana, mexico.
| Device | OXIFIRST(TM) FETAL SENSOR FS14-SERIES |
| Classification Name | Oximeter, Fetal Pulse |
| Generic Name | Oximeter, Fetal Pulse |
| Applicant | Covidien, LLC |
| Date Received | 2001-06-05 |
| Decision Date | 2001-12-19 |
| PMA | P990053 |
| Supplement | S002 |
| Product Code | MMA |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Express Gmp Supplement |
| 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 |