COLLAGRAFT(TM) BONE GRAFT MATRIX
FDA premarket approval P900039/S008 · decided 1995-10-30
Approval details
- PMA number
- P900039
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COLLAGRAFT(TM) BONE GRAFT MATRIX
- Generic name
- Filler, bone void, non-osteoinduction
- Applicant
- Neucoll, Inc.
- Date received
- 1995-07-28
- Decision date
- 1995-10-30
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- MBS
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Los Gatos, CA
- Statement
- APPROVAL FOR MODIFICATIONS OT THE PRODUCT LABELING PERTAINING TO POLYMYOSITIS(PM)/DERMATOMYOSITIS(DM)
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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 |