13C-Spirulina Gastric Emptying Breath Test (GEBT)

FDA Premarket Approval P110015 S008

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 a change to labeling that will facilitate telehealth administration of the device

• Device: 13C-Spirulina Gastric Emptying Breath Test (GEBT)
• Generic Name: Gastric Emptying Breath Test
• Applicant: ADVANCED BREATH DIAGNOSTICS
• Date Received: 2021-03-16
• Decision Date: 2021-08-10
• PMA: P110015
• Supplement: S008
• Product Code: PGE
• Advisory Committee: Clinical Chemistry
• Supplement Type: Real-time Process
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: ADVANCED BREATH DIAGNOSTICS 105 Westpark Dr. suite 150 brentwood, TN 37027

Supplemental Filings

Supplement Number	Date	Supplement Type
P110015		Original Filing
S010	2022-05-03	30-day Notice
S009
S008	2021-03-16	Real-time Process
S007	2021-02-23	30-day Notice
S006	2019-10-30	30-day Notice
S005	2019-03-05	135 Review Track For 30-day Notice
S004	2018-06-14	30-day Notice
S003
S002	2016-07-15	135 Review Track For 30-day Notice
S001

NIH GUDID Devices

Device ID	PMA	Supp
M763K0211	P110015	000