AVITENE ULTRA WRAP COLLAGEN HEMOSTAT
FDA premarket approval N17600/S019 · decided 2001-12-06
Approval details
- PMA number
- N17600
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AVITENE ULTRA WRAP COLLAGEN HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- Date received
- 2001-10-18
- Decision date
- 2001-12-06
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Warwick, RI
- Statement
- APPROVAL FOR MANUFACTURING MODIFICATIONS TO THE AVITENE ULTRAFOAM CAST MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) SPONGE AND MODIFICATIONS TO THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AVITENE ULTRAWRAP COLLAGEN HEMOSTAT AND IS INDICATED FOR USE IN SURGICAL PROCEDURES AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR CONVENTIONAL PROCEDURES IS INEFFECTIVE OR IMPRACTICAL.
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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 |