Premarket Approval (PMA)

Note: 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.

• 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: S003
• Date Received: 05/28/2014
• Decision Date: 11/03/2014
• Withdrawal Date: 03/17/2025
• Product Code: PDR
• Advisory Committee: Anesthesiology
• Supplement Type: Normal 180 Day Track No User Fee
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.