PMA P820083S023
- Device
- GORE-TEX(TM) SUTURE
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P820083
- Supplement
- S023
- Product code
- GAW
- Decision date
- 1996-10-03
- Generic name
- Suture, nonabsorbable, synthetic, polypropylene
- Approval order statement
- ADDITION OF TWO NEW INDICATIONS: FOR USE IN THE REPAIR OF DURA MATER AND FOR USE IN THE REPAIR OF REPLACEMENT OF CHORDAE TENDINEAE
Current openFDA PMA Record#
- Device
- GORE-TEX(TM) SUTURE
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P820083
- Supplement
- S023
- Product code
- GAW
- Generic name
- Suture, nonabsorbable, synthetic, polypropylene
- Decision date
- 1996-10-03
- Decision code
- APPR
- Date received
- 1996-09-16
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- ADDITION OF TWO NEW INDICATIONS: FOR USE IN THE REPAIR OF DURA MATER AND FOR USE IN THE REPAIR OF REPLACEMENT OF CHORDAE TENDINEAE