NEUGRAFT
FDA premarket approval P900039/S013 · decided 2004-06-07
Approval details
- PMA number
- P900039
- Supplement
- S013
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NEUGRAFT
- Generic name
- Filler, bone void, non-osteoinduction
- Applicant
- Neucoll, Inc.
- Date received
- 2004-04-30
- Decision date
- 2004-06-07
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- MBS
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Los Gatos, CA
- Statement
- APPROVAL FOR THE ADDITION OF THE PRODUCT "NEUGRAFT". COLLAGRAFT STRIP BONE GRAFT MATRIX (COLLAGRAFT) WAS ORIGINALLY APPROVED BY THE FDA ON JANUARY 27, 1994 (REVIEW OF P900039). THE PRODUCT CURRENTLY CONTINUES TO BE MARKETED BY THAT NAME. NEUGRAFT IS IDENTICAL TO COLLAGRAFT STRIP BONE GRAFT MATRIX, EXCEPT THAT THE BRAND NAME ON THE LABELING IS DIFFERENT. THE LABELING FOR NEUGRAFT INDICATED AND EXPLAINS THAT THE TWO PRODUCTS ARE THE SAME, BUT ARE SOLD THROUGH DIFFERENT DISTRIBUTION CHANNELS. AS PR
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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 |