ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
FDA premarket approval P100022/S009 · decided 2013-10-16
Approval details
- PMA number
- P100022
- Supplement
- S009
- Supplement type
- 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
- 2013-09-20
- Decision date
- 2013-10-16
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- MODIFY THE HANDLE ASSEMBLY AND PUSHER CANNULA/HOLDING BUSHING BONDING PROCESSES FOR THE ZILVER PTX DRUG-ELUTING PERIPHERAL STENTS.
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