ZILVER PTX DRUG ELUTING PERIPHERAL STENT
FDA premarket approval P100022/S006 · decided 2013-07-19
Approval details
- PMA number
- P100022
- Supplement
- S006
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ZILVER PTX DRUG ELUTING PERIPHERAL STENT
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2013-06-19
- Decision date
- 2013-07-19
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.