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 software changes to pulse oximeter artifact mitigation period, redundant pulse oximetry signal quality advisory, allotted time for pulse oximeter synchronization (reset and return to normal operation), and the ability to select clinician response (manual) mode after starting treatment using automated response mode.
| 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 | 2015-11-18 |
| Decision Date | 2016-02-12 |
| PMA | P080009 |
| Supplement | S011 |
| Product Code | PDR |
| Advisory Committee | Anesthesiology |
| Supplement Type | Real-time Process |
| 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 |