ZILVER PTX DRUG ELUTING PERIPHERAL STENT
FDA premarket approval P100022/S010 · decided 2015-01-07
Approval details
- PMA number
- P100022
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2014-04-17
- Decision date
- 2015-01-07
- Days to decision
- 265 days
- Decision code
- APPR
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT NORMAN NOBLE, INC., HIGHLAND HEIGHTS, OHIO.
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