PMA P080009S008

Device: SEDASYS COMPUTER ASSISTED PERSONALIZED SEDATION SYSTEM
Applicant: Scott Laboratories, Inc.
PMA number: P080009
Supplement: S008
Product code: PDR
Decision date: 2015-07-16
Classification: Computer-assisted Personalized Sedation System
Generic name: Computer-assisted personalized sedation system
Approval order statement: APPROVAL FOR CHANGES TO THE CLINICAL USER GUIDE/ OPERATORS MANUAL TO PRECAUTION AGAINST THE USE OF QUATERNARY AMMONIUM COMPOUND (QAC)-BASED DISINFECTANTS.

Current openFDA PMA Record#

Device: SEDASYS COMPUTER ASSISTED PERSONALIZED SEDATION SYSTEM
Applicant: Scott Laboratories, Inc.
PMA number: P080009
Supplement: S008
Product code: PDR
Generic name: Computer-assisted personalized sedation system
Decision date: 2015-07-16
Decision code: APPR
Date received: 2015-06-16
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES TO THE CLINICAL USER GUIDE/ OPERATORS MANUAL TO PRECAUTION AGAINST THE USE OF QUATERNARY AMMONIUM COMPOUND (QAC)-BASED DISINFECTANTS.