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 changes to the clinical user guide/ operator¿s manual to warn against the use of quaternary ammonium compound (qac)-based disinfectants (specifically those containing ammonium chlorides). Additionally, affixing two labels to the exterior of the device which reiterate this warning.
| 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 | 2015-09-08 |
| Decision Date | 2015-10-08 |
| PMA | P080009 |
| Supplement | S009 |
| Product Code | PDR |
| Advisory Committee | Anesthesiology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Scott Laboratories, Inc 2804 N. Loop 289 lubbock, TX 79415 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P080009 | Original Filing | |
| 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 |