PMA P800012S008
- Device
- DRILAC GRANULES
- Applicant
- OSMED, INC.
- PMA number
- P800012
- Supplement
- S008
- Product code
- LPG
- Decision date
- 2002-03-05
- Generic name
- Material, Dressing, Surgical, Polylactic Acid
- Approval order 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.
Current openFDA PMA Record
- Device
- DRILAC GRANULES
- Applicant
- Osmed, Inc.
- PMA number
- P800012
- Supplement
- S008
- Product code
- LPG
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Decision date
- 2002-03-05
- Decision code
- APPR
- Date received
- 2002-01-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order 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.