|
Device | SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM |
Generic Name | Computer-assisted personalized sedation system |
Applicant | Scott Laboratories, Inc 2804 N. Loop 289 Lubbock, TX 79415 |
PMA Number | P080009 |
Date Received | 03/25/2008 |
Decision Date | 05/03/2013 |
Product Code |
PDR |
Docket Number | 13M-0549 |
Notice Date | 05/08/2013 |
Advisory Committee |
Anesthesiology |
Clinical Trials | NCT00452426
|
Expedited Review Granted? | Yes |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE SEDASYS® COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM. THIS DEVICE IS INDICATED FOR THE INTRAVENOUS ADMINISTRATION OF 1% (10 MG/ML) PROPOFOL INJECTABLE EMULSION FOR THE INITIATION ANDMAINTENANCE OF MINIMAL TO MODERATE SEDATION, AS DEFINED BY THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) CONTINUUM OF DEPTH OF SEDATION, IN ASA PHYSICAL STATUS I AND II PATIENTS >= 18 YEARS OLD UNDERGOING COLONOSCOPY AND ESOPHAGOGASTRODUOD-DENOSCOPY (EGD) PROCEDURES. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S007 S008 S009 S010 S011 S012
|