PMA P150024S011
- Device
- AspireAssist
- Applicant
- Aspire Bariatrics, Inc.
- PMA number
- P150024
- Supplement
- S011
- Product code
- OYF
- Decision date
- 2018-06-19
- Classification
- Aspiration Therapy System
- Generic name
- Aspiration therapy system
- Approval order statement
- Approval for changes to the A-tube IFU, Physician Guide and Patient Guide.
Current openFDA PMA Record#
- Device
- AspireAssist
- Applicant
- Aspire Bariatrics, Inc.
- PMA number
- P150024
- Supplement
- S011
- Product code
- OYF
- Generic name
- Aspiration therapy system
- Decision date
- 2018-06-19
- Decision code
- APPR
- Date received
- 2018-05-22
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the A-tube IFU, Physician Guide and Patient Guide.