PMA P080009S007
- Device
- SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
- Applicant
- Scott Laboratories, Inc.
- PMA number
- P080009
- Supplement
- S007
- Product code
- PDR
- Decision date
- 2015-10-06
- Classification
- Computer-assisted Personalized Sedation System
- Generic name
- Computer-assisted personalized sedation system
- Approval order statement
- APPROVAL FOR SOFTWARE CHANGES TO RESOLVE THREE ANOMALIES.
Current openFDA PMA Record#
- Device
- SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
- Applicant
- Scott Laboratories, Inc.
- PMA number
- P080009
- Supplement
- S007
- Product code
- PDR
- Generic name
- Computer-assisted personalized sedation system
- Decision date
- 2015-10-06
- Decision code
- APPR
- Date received
- 2015-04-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE CHANGES TO RESOLVE THREE ANOMALIES.