PMA P820083S025

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.