PMA P820083
- Device
- GORE-TEX(TM) SUTURE
- Applicant
- W.L. GORE & ASSOCIATES,INC
- PMA number
- P820083
- Supplement
- S025
- Product code
- GAW
- Decision date
- 1998-08-27
- Generic name
- Suture, Nonabsorbable, Synthetic, Polypropylene
- Approval order statement
- Approval For 1) A Change In Suture Needle Material 2) A Change In Suture Needle Geometry, And 3) Addition Of A Silicone Coating To The Suture Needle.
Current openFDA PMA Record
- Device
- GORE-TEX(TM) SUTURE
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P820083
- Supplement
- S025
- Product code
- GAW
- Generic name
- Suture, nonabsorbable, synthetic, polypropylene
- Decision date
- 1998-08-27
- Decision code
- APPR
- Date received
- 1998-07-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for 1) a change in suture needle material 2) a change in suture needle geometry, and 3) addition of a silicone coating to the suture needle.