|
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 | S005 |
Date Received | 01/29/2015 |
Decision Date | 03/25/2015 |
Product Code |
PDR |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE CHANGES TO THE POST-APPROVAL STUDY PROTOCOL. |