DRILAC{TM} CUBES / GRANULES
FDA premarket approval P800012/S006 · decided 1994-06-28
Approval details
- PMA number
- P800012
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DRILAC{TM} CUBES / GRANULES
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Osmed, Inc.
- Date received
- 1993-03-11
- Decision date
- 1994-06-28
- Days to decision
- 474 days
- Decision code
- APPR
- Product code
- LPG
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Duluth, MN
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