PMA P080009S001
- Device
- SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
- Applicant
- Scott Laboratories, Inc.
- PMA number
- P080009
- Supplement
- S001
- Product code
- PDR
- Decision date
- 2014-06-16
- Classification
- Computer-assisted Personalized Sedation System
- Generic name
- Computer-assisted personalized sedation system
- Approval order statement
- APPROVAL FOR DESIGN MODIFICATIONS TO THE HARDWARE, FIRMWARE, AND SOFTWARE AND A NEW MANUFACTURING FACILITY AT FLEX MEDICAL IN TIJUANA, MEXICO.
Current openFDA PMA Record#
- Device
- SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
- Applicant
- Scott Laboratories, Inc.
- PMA number
- P080009
- Supplement
- S001
- Product code
- PDR
- Generic name
- Computer-assisted personalized sedation system
- Decision date
- 2014-06-16
- Decision code
- APPR
- Date received
- 2013-06-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR DESIGN MODIFICATIONS TO THE HARDWARE, FIRMWARE, AND SOFTWARE AND A NEW MANUFACTURING FACILITY AT FLEX MEDICAL IN TIJUANA, MEXICO.