ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
FDA premarket approval P100022/S016 · decided 2015-10-26
Approval details
- PMA number
- P100022
- Supplement
- S016
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2015-07-24
- Decision date
- 2015-10-26
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- APPROVAL FOR THE ADDITION OF A STENT RECLAIM PROCESS.
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