COLLAGRAFT STRIP BONE GRAFT MATRIX
FDA premarket approval P900039/S011 · decided 2002-07-02
Approval details
- PMA number
- P900039
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- COLLAGRAFT STRIP BONE GRAFT MATRIX
- Generic name
- Filler, bone void, non-osteoinduction
- Applicant
- Neucoll, Inc.
- Date received
- 2001-09-19
- Decision date
- 2002-07-02
- Days to decision
- 286 days
- Decision code
- APPR
- Product code
- MBS
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Los Gatos, CA
- Statement
- APPROVAL FOR ADDITION MANUFACTURING SITES LOCATED AT: BIOSERV CORPORATION, SAN DIEGO, CALIFORNIA; BIOLOGICAL TEST CENTER, B. BRAUN MEDICAL, INC., IRVINE, CALIFORNIA; NEUCOLL, INC., CAMBELL, CALIFORNIA; AND PHARMACEUTICAL SYSTEMS, INC., MUNDALEIN, ILLINOIS.
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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 |