PERIOGARD PERIODONTAL TISSUE MONITOR
FDA premarket approval P960031 · decided 1997-06-23
Approval details
- PMA number
- P960031
- Trade name
- PERIOGARD PERIODONTAL TISSUE MONITOR
- Applicant
- Xytronyx, Inc.
- Date received
- 1996-09-19
- Decision date
- 1997-06-23
- Days to decision
- 277 days
- Decision code
- APWD
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR THE PERIOGARD PERIODONTAL TISSUE MONITOR (PTM). THIS DEVICE IS INDICATED FOR USE AS A RAPID, CHAIR-SIDE, VISUAL TEST FOR THE QUALITATIVE DETERMINATION OF ASPARTATE AMINOTRANSFERASE (AST) IN GINGIVAL CREVICULAR FLUID. THE PTM KIT DETECTS ELEVATED LEVELS OF AST ASSOCAITED WITH TISSUE NECROSIS. IT IS INTENDED TO BE USED AS AN OBJECTIVE, BIOCHEMICAL ADJUNCT TO TRADITIONAL METHODS OF MONITORING PATIENTS TO ASSIST IN THE DECISION TO APPLY TREATMENT AND IN THE EVALUATION OF TREATMENT EFFEC
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.