PMA P820083S021
- Device
- GORE-TEX(R) SUTURE
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P820083
- Supplement
- S021
- Product code
- GAW
- Decision date
- 1996-09-24
- Generic name
- Suture, nonabsorbable, synthetic, polypropylene
- Approval order statement
- APPROVAL FOR COMBINING EPTFE PLEDGETS WITH GORE-TEX SUTURE AND APPROVAL FOR MODIFIED PACKAGING OF THE GORE-TEX SUTURE
Current openFDA PMA Record#
- Device
- GORE-TEX(R) SUTURE
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P820083
- Supplement
- S021
- Product code
- GAW
- Generic name
- Suture, nonabsorbable, synthetic, polypropylene
- Decision date
- 1996-09-24
- Decision code
- APPR
- Date received
- 1996-09-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR COMBINING EPTFE PLEDGETS WITH GORE-TEX SUTURE AND APPROVAL FOR MODIFIED PACKAGING OF THE GORE-TEX SUTURE