PMA P150024S010

Device: AspireAssist
Applicant: Aspire Bariatrics, Inc.
PMA number: P150024
Supplement: S010
Product code: OYF
Decision date: 2019-01-15
Classification: Aspiration Therapy System
Generic name: Aspiration therapy system
Approval order statement: Approval of the revised protocol with modifications including use of local labs for blood work, changes to the minimum and maximum number of patients enrolled per site, and a revised study timeline for the post-approval study (PAS) protocol.

Current openFDA PMA Record#

Device: AspireAssist
Applicant: Aspire Bariatrics, Inc.
PMA number: P150024
Supplement: S010
Product code: OYF
Generic name: Aspiration therapy system
Decision date: 2019-01-15
Decision code: APPR
Date received: 2018-05-01
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the revised protocol with modifications including use of local labs for blood work, changes to the minimum and maximum number of patients enrolled per site, and a revised study timeline for the post-approval study (PAS) protocol.