Pathway Clinical Trial Cohort

FDA Premarket Approval P150024 S016

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 including the ode lead pma post-approval study - extended follow-up of the premarket cohort (pathway clinical trial) has been fulfilled.

DevicePathway Clinical Trial Cohort
Generic NameAspiration Therapy System
ApplicantASPIRE BARIATRICS INC
Date Received2019-10-29
Decision Date2020-04-24
PMAP150024
SupplementS016
Product CodeOYF 
Advisory CommitteeGastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination Product No
Applicant Address ASPIRE BARIATRICS INC 3200 Horizon Drive suite 100 king Of Prussia, PA 19406

Supplemental Filings

Supplement NumberDateSupplement Type
P150024Original 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 IDPMASupp
10857808005471 P150024 000
10857808005044 P150024 000
10857808005037 P150024 000
10857808005020 P150024 000
10857808005013 P150024 000

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