This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
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.
| Device | SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM |
| Classification Name | Computer-assisted Personalized Sedation System |
| Generic Name | Computer-assisted Personalized Sedation System |
| Applicant | Scott Laboratories, Inc |
| Date Received | 2008-03-25 |
| Decision Date | 2013-05-03 |
| Notice Date | 2013-05-08 |
| PMA | P080009 |
| Supplement | S |
| Product Code | PDR |
| Docket Number | 13M-0549 |
| Advisory Committee | Anesthesiology |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | Scott Laboratories, Inc 2804 N. Loop 289 lubbock, TX 79415 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P080009 | Original Filing | |
| S012 | ||
| S011 | 2015-11-18 | Real-time Process |
| S010 | 2015-10-28 | Real-time Process |
| S009 | 2015-09-08 | Special (immediate Track) |
| S008 | 2015-06-16 | Special (immediate Track) |
| S007 | 2015-04-06 | Real-time Process |
| S006 | ||
| S005 | 2015-01-29 | Normal 180 Day Track No User Fee |
| S004 | ||
| S003 | 2014-05-28 | Normal 180 Day Track No User Fee |
| S002 | 2014-05-28 | Normal 180 Day Track No User Fee |
| S001 | 2013-06-27 | Normal 180 Day Track |