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 design modifications to the hardware, firmware, and software and a new manufacturing facility at flex medical in tijuana, mexico.
| 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 | 2013-06-27 |
| Decision Date | 2014-06-16 |
| PMA | P080009 |
| Supplement | S001 |
| Product Code | PDR |
| Advisory Committee | Anesthesiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |