PMA P120002S007
- Device
- CORDIS S.M.A.R.T.AND S.M.A.R.T.CONTROL VASCULAR STENT SYSTEM
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S007
- Product code
- NIP
- Decision date
- 2016-05-09
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Approval for updated labeling to include the post-approval study results.
Current openFDA PMA Record#
- Device
- CORDIS S.M.A.R.T.AND S.M.A.R.T.CONTROL VASCULAR STENT SYSTEM
- Applicant
- Cordis US Corporation
- PMA number
- P120002
- Supplement
- S007
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2016-05-09
- Decision code
- APPR
- Date received
- 2015-03-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updated labeling to include the post-approval study results.