| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | ETHIZIA |
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| Generic Name | Agent, absorbable hemostatic, collagen with polymeric additives |
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| Regulation Number | 878.4490 |
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| Applicant | ETHICON, Inc.
1000 Rte. 202
Raritan, NJ 08869 |
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| PMA Number | P240035 |
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| Date Received | 10/17/2024 |
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| Decision Date | 12/15/2025 |
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| Product Code |
SGV |
| Docket Number | 25M-7110 |
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| Notice Date | 12/16/2025 |
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| Advisory Committee |
General & Plastic Surgery |
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| Clinical Trials | NCT04819945
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for ETHIZIA™ indicated for use in adult patients with a body weight of greater than or equal to 25kg as an adjunct to hemostasis in open liver surgery for minimal, mild, or moderate bleeding sites when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling |
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S003 S005 S006 S001 S002 |
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