AVITENE ULTRAFOAM MICROFIBRILLAR COLLAGEN HEMOSTAT SPONGE
FDA premarket approval N17600/S027 · decided 2013-06-27
Approval details
- PMA number
- N17600
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AVITENE ULTRAFOAM MICROFIBRILLAR COLLAGEN HEMOSTAT SPONGE
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- Date received
- 2013-05-28
- Decision date
- 2013-06-27
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Warwick, RI
- Statement
- REVISED LAL (ENDOTOXIN) TEST FOR THE AVITENE® ULTRAFOAM® MICROFIBRILLAR COLLAGEN HEMOSTAT SPONGE MANUFACTURED AT THE WOBURN MASSACHUSETTS SITE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VENTRALIGHT ST MESH (K101851) | Davol Inc., Sub. C. R. Bard, Inc. | 2010-07-15 |
| BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 (K092032) | Davol Inc., Sub. C. R. Bard, Inc. | 2009-12-08 |
| BARD 3DMAX MESH (K081010) | Davol Inc., Sub. C. R. Bard, Inc. | 2008-10-07 |
| BARD COMPOSITE L/P MESH (K061754) | Davol Inc., Sub. C. R. Bard, Inc. | 2006-10-23 |
| BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH (K061314) | Davol Inc., Sub. C. R. Bard, Inc. | 2006-06-02 |
| SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 (K051848) | Davol Inc., Sub. C. R. Bard, Inc. | 2005-08-11 |
| SALUTE FIXATION SYSTEM (K050610) | Davol Inc., Sub. C. R. Bard, Inc. | 2005-05-25 |
| AQUASENS FLUID MONITORING SYSTEM (K011069) | Davol Inc., Sub. C. R. Bard, Inc. | 2001-08-16 |