PMA P150024S016
- Device
- Pathway Clinical Trial Cohort
- Applicant
- Aspire Bariatrics, Inc.
- PMA number
- P150024
- Supplement
- S016
- Product code
- OYF
- Decision date
- 2020-04-24
- Generic name
- Aspiration therapy system
- Approval order statement
- Approval including the ODE Lead PMA Post-Approval Study - Extended Follow-up of the Premarket Cohort (PATHWAY Clinical Trial) has been fulfilled.
Current openFDA PMA Record#
- Device
- Pathway Clinical Trial Cohort
- Applicant
- Aspire Bariatrics, Inc.
- PMA number
- P150024
- Supplement
- S016
- Product code
- OYF
- Generic name
- Aspiration therapy system
- Decision date
- 2020-04-24
- Decision code
- APPR
- Date received
- 2019-10-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval including the ODE Lead PMA Post-Approval Study - Extended Follow-up of the Premarket Cohort (PATHWAY Clinical Trial) has been fulfilled.