COLLAGRAFT STRIP BONE GRAFT MATRIX
FDA premarket approval P900039/S010 · decided 1998-12-07
Approval details
- PMA number
- P900039
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLAGRAFT STRIP BONE GRAFT MATRIX
- Generic name
- Filler, bone void, non-osteoinduction
- Applicant
- Neucoll, Inc.
- Date received
- 1998-11-23
- Decision date
- 1998-12-07
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- MBS
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Los Gatos, CA
- Statement
- Approval for changes to your manufacturing process. These changes involve 1) moving some of the manufacturing operations currently performed in a Class 100 room to a "controlled" environment that provides the equivalent of a Class 10,000 environment, 2) increasing the "hold" time between the remisturization and irradiation processes, and 3) eliminating both the protein concentration assay for past homogenate mixing and the LAL pyrogenicity assay, as described in the supplement.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX) (K000122) | Neucoll, Inc. | 2001-09-20 |