AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB/ENDOAVITENE
FDA premarket approval P800002/S018 · decided 2012-01-23
Approval details
- PMA number
- P800002
- Supplement
- S018
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB/ENDOAVITENE
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- C.R. Bard, Inc.
- Date received
- 2011-12-22
- Decision date
- 2012-01-23
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- APPROVAL FOR THE ADDITION OF A PRECAUTIONS SECTION TO THE INSTRUCTIONS FOR USE FOR THE AVITENE FAMILY OF PRODUCTS. THE ADDITIONAL LANGUAGE IS AS FOLLOWS: "ANY EXCESS AVITENE MCH NOT REMOVED AT THE TIME OF SURGERY MAY EITHER PRESENT ITSELF AS A (RECURRING) MASS OR A (SPACE OCCUPYING) LESION OR IT MAY LEAD TO A FOREIGN BODY REACTION THAT MAYPRESENT WITH OR WITHOUT CLINICAL SIGNS AND SYMPTOMS AS A RECURRING MASS OR LESION OR POSTOPERATIVE ABSCESS FORMATION UPON IMAGING. IMAGING MAY INITIALLY NOT BE
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