|
Device | MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR |
Generic Name | VENTILATOR, HIGH FREQUENCY |
Applicant | Covidien 6135 GUNBARREL AVE. BOULDER, CO 80301 |
PMA Number | P890034 |
Supplement Number | S005 |
Date Received | 06/12/1995 |
Decision Date | 12/28/1995 |
Withdrawal Date
|
02/25/2011 |
Product Code |
LSZ |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN PROXIMAL MONITORING ENDOTRACHEAL TUBE ADAPTER FOR USE WITH THE ADULT STAR MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR - THE PROXIMAL MONITORING ADAPTER WILL BE MARKETED UNDER THE NEW TRADE NAME AS THE "PROXIMAL MONITORING ADAPTER" |