AspireAssist

Aspiration Therapy System

FDA Premarket Approval P150024 S011

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for changes to the a-tube ifu, physician guide and patient guide.

• Device: AspireAssist
• Classification Name: Aspiration Therapy System
• Generic Name: Aspiration Therapy System
• Applicant: ASPIRE BARIATRICS INC
• Date Received: 2018-05-22
• Decision Date: 2018-06-19
• PMA: P150024
• Supplement: S011
• Product Code: OYF
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Special (immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: ASPIRE BARIATRICS INC 3200 Horizon Drive suite 100 king Of Prussia, PA 19406

Supplemental Filings

Supplement Number	Date	Supplement Type
P150024		Original Filing
S016	2019-10-29	Normal 180 Day Track No User Fee
S015
S014
S013
S012	2018-09-25	Special (immediate Track)
S011	2018-05-22	Special (immediate Track)
S010	2018-05-01	Normal 180 Day Track No User Fee
S009	2018-02-07	Special (immediate Track)
S008	2018-01-19	Normal 180 Day Track
S007
S006	2017-03-27	Real-time Process
S005	2016-10-17	Normal 180 Day Track No User Fee
S004	2016-08-16	Real-time Process
S003	2016-08-15	Special (immediate Track)
S002
S001	2016-07-29	Special (immediate Track)

NIH GUDID Devices

Device ID	PMA	Supp
10857808005471	P150024	000
10857808005044	P150024	000
10857808005037	P150024	000
10857808005020	P150024	000
10857808005013	P150024	000