PMA P150024S009

Device
AspireAssist
Applicant
Aspire Bariatrics, Inc.
PMA number
P150024
Supplement
S009
Product code
OYF
Decision date
2018-02-23
Classification
Aspiration Therapy System
Generic name
Aspiration therapy system
Approval order statement
Approval for a workbook for patients, Pathway to a healthier you.

Current openFDA PMA Record#

Device
AspireAssist
Applicant
Aspire Bariatrics, Inc.
PMA number
P150024
Supplement
S009
Product code
OYF
Generic name
Aspiration therapy system
Decision date
2018-02-23
Decision code
APPR
Date received
2018-02-07
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for a workbook for patients, Pathway to a healthier you.