PMA N17600S019
- Device
- AVITENE ULTRA WRAP COLLAGEN HEMOSTAT
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- PMA number
- N17600
- Supplement
- S019
- Product code
- LMF
- Decision date
- 2001-12-06
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order 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.
Current openFDA PMA Record#
- Device
- AVITENE ULTRA WRAP COLLAGEN HEMOSTAT
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- PMA number
- N17600
- Supplement
- S019
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2001-12-06
- Decision code
- APPR
- Date received
- 2001-10-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.