PMA P110040S007
- Device
- COMPLETE SE VASCULAR STENT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P110040
- Supplement
- S007
- Product code
- NIP
- Decision date
- 2016-02-25
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Approval for updating the labeling to include the post-approval study results.
Current openFDA PMA Record#
- Device
- COMPLETE SE VASCULAR STENT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P110040
- Supplement
- S007
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2016-02-25
- Decision code
- APPR
- Date received
- 2015-06-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updating the labeling to include the post-approval study results.