PMA P100022S001
- Device
- ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S001
- Product code
- NIU
- Decision date
- 2013-06-03
- Classification
- Stent, Superficial Femoral Artery, Drug-eluting
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- APPROVAL FOR A PRODUCT LINE EXTENSION FOR THE ZILVER PTX DRUG-ELUTING PERIPHERAL STENT. THIS LINE EXTENSION INCLUDES ADDITIONAL STENT LENGTHS OF 100MM AND 120MM.
Current openFDA PMA Record#
- Device
- ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S001
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2013-06-03
- Decision code
- APPR
- Date received
- 2012-12-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A PRODUCT LINE EXTENSION FOR THE ZILVER PTX DRUG-ELUTING PERIPHERAL STENT. THIS LINE EXTENSION INCLUDES ADDITIONAL STENT LENGTHS OF 100MM AND 120MM.