GORE-TEX SUTURE WITH PLEDGETS
FDA premarket approval P820083/S022 · decided 1996-09-24
Approval details
- PMA number
- P820083
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GORE-TEX SUTURE WITH PLEDGETS
- Generic name
- Suture, nonabsorbable, synthetic, polypropylene
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 1996-09-03
- Decision date
- 1996-09-24
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- GAW
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- APPROVAL FOR COMBINING EPTFE PLEDGETS WITH GORE-TEX SUTURE AND APPROVAL FOR MODIFIED PACKAGING OF THE GORE-TEX SUTURE
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| GORE® Tri-Lobe Balloon Catheter (K250410) | W. L. Gore & Associates, Inc. | 2025-06-02 |
| GORE® PROPATEN® Vascular Graft (K240083) | W. L. Gore & Associates, Inc. | 2024-03-01 |
| GORE® PROPATEN® Vascular Graft (K232312) | W. L. Gore & Associates, Inc. | 2024-01-09 |
| GORE® ACUSEAL Vascular Graft (K233551) | W. L. Gore & Associates, Inc. | 2023-12-19 |
| GORE® ACUSEAL Vascular Graft (K231505) | W. L. Gore & Associates, Inc. | 2023-06-23 |
| GORE BIO-A Tissue Reinforcement (K191773) | W. L. Gore & Associates, Inc. | 2019-07-31 |
| GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (K181940) | W. L. Gore & Associates, Inc. | 2018-08-17 |
| GORE ENFORM Biomaterial (K173333) | W. L. Gore & Associates, Inc. | 2018-04-05 |