PMA P100022S008
- Device
- ZILVER PTX DRUG ELUTING PERIPHERAL STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S008
- Product code
- NIU
- Decision date
- 2013-10-22
- Classification
- Stent, Superficial Femoral Artery, Drug-eluting
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- APPROVAL FOR TIGHTENING THE DRUG POTENCY SPECIFICATION AND EXPANSION OF YOUR DEVICE SHELF-LIFE FROM 6 MONTHS TO 12 MONTHS.
Current openFDA PMA Record#
- Device
- ZILVER PTX DRUG ELUTING PERIPHERAL STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S008
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2013-10-22
- Decision code
- APPR
- Date received
- 2013-07-22
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR TIGHTENING THE DRUG POTENCY SPECIFICATION AND EXPANSION OF YOUR DEVICE SHELF-LIFE FROM 6 MONTHS TO 12 MONTHS.