AVITENE MICROFIBIBRILLAR COLLAGEN HEMOSTAT PRODUCTS- NON-WOVEN WEB, ULTRAFOAM, FLOUR, 1G SYRINGE, ENDO AVIETENE
FDA premarket approval P800002/S021 · decided 2014-06-26
Approval details
- PMA number
- P800002
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AVITENE MICROFIBIBRILLAR COLLAGEN HEMOSTAT PRODUCTS- NON-WOVEN WEB, ULTRAFOAM, FLOUR, 1G SYRINGE, ENDO AVIETENE
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- C.R. Bard, Inc.
- Date received
- 2014-05-30
- Decision date
- 2014-06-26
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- FOIL POUCH SUPPLIER FACILITY SITE CHANGE AND THE PROPOSED REMOVAL OF A REJECTION CRITERION FOR COMPONENT ACCEPTANCE IN AN IN-PROCESS INSPECTION STEP FOR THE AVITENE PRODUCT FAMILY.
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