DRILAC CUBES AND GRANULES
FDA premarket approval P800012/S010 · decided 2002-10-09
Approval details
- PMA number
- P800012
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DRILAC CUBES AND GRANULES
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Osmed, Inc.
- Date received
- 2002-09-09
- Decision date
- 2002-10-09
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LPG
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Duluth, MN
- Statement
- APPROVAL FOR CHANGES TO THE DIRECTIONS FOR USE LABELING.
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