|
Device | 13 C-Spirulina Gastric Emptying Breath Test (GEBT) |
Generic Name | Gastric Emptying Breath Test |
Applicant | ADVANCED BREATH DIAGNOSTICS 105 WESTPARK DR. SUITE 150 BRENTWOOD, TN 37027 |
PMA Number | P110015 |
Supplement Number | S007 |
Date Received | 02/23/2021 |
Decision Date | 03/16/2021 |
Product Code |
PGE |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Changes to the quality control process used during the manufacture of the 13C-Spirulina substrate. The substrate is a component of the GEBT. |