|
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 |
Supplement Number | S007 |
Date Received | 04/06/2015 |
Decision Date | 10/06/2015 |
Product Code |
PDR |
Advisory Committee |
Anesthesiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR SOFTWARE CHANGES TO RESOLVE THREE ANOMALIES. |