PMA P080009S004
- Device
- SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEMS
- Applicant
- Scott Laboratories, Inc.
- Product code
- PDR
- Decision date
- 2015-03-23
- Generic name
- Computer-assisted personalized sedation system
- Approval order statement
- APPROVAL OF THE CHANGES TO THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEMS
- Applicant
- Scott Laboratories, Inc.
- PMA number
- P080009
- Supplement
- S004
- Product code
- PDR
- Generic name
- Computer-assisted personalized sedation system
- Decision date
- 2015-03-23
- Decision code
- APPR
- Date received
- 2015-01-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE CHANGES TO THE POST-APPROVAL STUDY PROTOCOL.