PMA P100022S010
- Device
- ZILVER PTX DRUG ELUTING PERIPHERAL STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S010
- Product code
- NIU
- Decision date
- 2015-01-07
- Classification
- Stent, Superficial Femoral Artery, Drug-eluting
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT NORMAN NOBLE, INC., HIGHLAND HEIGHTS, OHIO.
Current openFDA PMA Record#
- Device
- ZILVER PTX DRUG ELUTING PERIPHERAL STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S010
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2015-01-07
- Decision code
- APPR
- Date received
- 2014-04-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT NORMAN NOBLE, INC., HIGHLAND HEIGHTS, OHIO.