PMA P100022S011
- Device
- ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S011
- Product code
- NIU
- Decision date
- 2015-01-13
- Classification
- Stent, Superficial Femoral Artery, Drug-eluting
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- APPROVAL TO THE POST-APPROVAL STUDY FOR THE DEVICE TO ALLOW FOR ENROLLMENT OF JAPANESE PMS PATIENTS WITH LESION LENGTH UP TO 200 MM PER LIMB IS COMPLETE.
Current openFDA PMA Record#
- Device
- ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S011
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2015-01-13
- Decision code
- APPR
- Date received
- 2014-11-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL TO THE POST-APPROVAL STUDY FOR THE DEVICE TO ALLOW FOR ENROLLMENT OF JAPANESE PMS PATIENTS WITH LESION LENGTH UP TO 200 MM PER LIMB IS COMPLETE.