PMA P080009S009

Device: SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
Applicant: Scott Laboratories, Inc.
PMA number: P080009
Supplement: S009
Product code: PDR
Decision date: 2015-10-08
Classification: Computer-assisted Personalized Sedation System
Generic name: Computer-assisted personalized sedation system
Approval order statement: APPROVAL FOR CHANGES TO THE CLINICAL USER GUIDE/ OPERATOR¿S MANUAL TO WARN AGAINST THE USE OF QUATERNARY AMMONIUM COMPOUND (QAC)-BASED DISINFECTANTS (SPECIFICALLY THOSE CONTAINING AMMONIUM CHLORIDES). ADDITIONALLY, AFFIXING TWO LABELS TO THE EXTERIOR OF THE DEVICE WHICH REITERATE THIS WARNING.

Current openFDA PMA Record#

Device: SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
Applicant: Scott Laboratories, Inc.
PMA number: P080009
Supplement: S009
Product code: PDR
Generic name: Computer-assisted personalized sedation system
Decision date: 2015-10-08
Decision code: APPR
Date received: 2015-09-08
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/ OPERATOR¿S MANUAL TO WARN AGAINST THE USE OF QUATERNARY AMMONIUM COMPOUND (QAC)-BASED DISINFECTANTS (SPECIFICALLY THOSE CONTAINING AMMONIUM CHLORIDES). ADDITIONALLY, AFFIXING TWO LABELS TO THE EXTERIOR OF THE DEVICE WHICH REITERATE THIS WARNING.