PMA P160004S004
- Device
- GORE TIGRIS Vascular Stent
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160004
- Supplement
- S004
- Product code
- NIP
- Decision date
- 2017-06-19
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Modifications to an in-process dimensional inspection method, associated specifications, and sampling plan for a sub-component.
Current openFDA PMA Record#
- Device
- GORE TIGRIS Vascular Stent
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P160004
- Supplement
- S004
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2017-06-19
- Decision code
- OK30
- Date received
- 2017-05-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to an in-process dimensional inspection method, associated specifications, and sampling plan for a sub-component.