PMA P080009S012

Device: SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
Applicant: Scott Laboratories, Inc.
Product code: PDR
Decision date: 2016-03-15
Generic name: Computer-assisted personalized sedation system
Approval order statement: Approval for software changes to address previous software anomalies (modifications to the Bedside Monitoring Unit (BMU) software to address wireless driver-caused shutdowns, BMU software modifications to address noninvasive blood pressure (NIBP) measurements).

Current openFDA PMA Record#

Device: SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
Applicant: Scott Laboratories, Inc.
PMA number: P080009
Supplement: S012
Product code: PDR
Generic name: Computer-assisted personalized sedation system
Decision date: 2016-03-15
Decision code: APPR
Date received: 2015-12-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for software changes to address previous software anomalies (modifications to the Bedside Monitoring Unit (BMU) software to address wireless driver-caused shutdowns, BMU software modifications to address noninvasive blood pressure (NIBP) measurements).