DRILAC CUBES AND GRANULES
FDA premarket approval P800012/S009 · decided 2002-09-17
Approval details
- PMA number
- P800012
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- DRILAC CUBES AND GRANULES
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Osmed, Inc.
- Date received
- 2002-08-12
- Decision date
- 2002-09-17
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- LPG
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Duluth, MN
- Statement
- APPROVAL FOR NEW MANUFACTURING AND STERILIZATION SITES. THE MANUFACTURING SITE IS LOCATED AT KENSEY NASH CORPORATION, EXTON, PA. THE NEW STERILIZATION SITE IS LOCATED AT STERIS ISOMEDIX SERVICES, WHIPPANY, NJ.
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