PMA P100022S006

Device: ZILVER PTX DRUG ELUTING PERIPHERAL STENT
Applicant: Cook Ireland, Ltd.
PMA number: P100022
Supplement: S006
Product code: NIU
Decision date: 2013-07-19
Classification: Stent, Superficial Femoral Artery, Drug-eluting
Generic name: Stent, superficial femoral artery, drug-eluting
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE (IFU) TO IMPROVE CLARITY BY PROVIDING RECOMMENDATIONS FOR APPROPRIATE GUIDEWIRE SELECTION AND ADDITIONAL INSTRUCTIONS FOR WHEN RESISTANCE IS ENCOUNTERED DURING CATHETER USE.

Current openFDA PMA Record#

Device: ZILVER PTX DRUG ELUTING PERIPHERAL STENT
Applicant: Cook Ireland, Ltd.
PMA number: P100022
Supplement: S006
Product code: NIU
Generic name: Stent, superficial femoral artery, drug-eluting
Decision date: 2013-07-19
Decision code: APPR
Date received: 2013-06-19
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE (IFU) TO IMPROVE CLARITY BY PROVIDING RECOMMENDATIONS FOR APPROPRIATE GUIDEWIRE SELECTION AND ADDITIONAL INSTRUCTIONS FOR WHEN RESISTANCE IS ENCOUNTERED DURING CATHETER USE.