PERIOGARD PERIODONTAL TISSUE MONITOR
FDA premarket approval P960031/S001 · decided 1997-09-30
Approval details
- PMA number
- P960031
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PERIOGARD PERIODONTAL TISSUE MONITOR
- Applicant
- Xytronyx, Inc.
- Date received
- 1997-08-26
- Decision date
- 1997-09-30
- Days to decision
- 35 days
- Decision code
- APPR
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- San Diego, CA
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