DRILAC GRANULES
FDA premarket approval P800012/S008 · decided 2002-03-05
Approval details
- PMA number
- P800012
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- DRILAC GRANULES
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Osmed, Inc.
- Date received
- 2002-01-31
- Decision date
- 2002-03-05
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- LPG
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Duluth, MN
- Statement
- APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT KENSEY NASH CORPORATION, EXTON, PENNSYLVANIA. THE GRANULATION AND SYRINGE CUTTING PROCESSES WILL BE CONDUCTED AT THIS FACILITY.
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