ZILVER PTX DRUG ELUTING PERIPHERAL STENT
FDA premarket approval P100022/S008 · decided 2013-10-22
Approval details
- PMA number
- P100022
- Supplement
- S008
- Supplement type
- Real-Time Process
- 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
- 2013-07-22
- Decision date
- 2013-10-22
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- APPROVAL FOR TIGHTENING THE DRUG POTENCY SPECIFICATION AND EXPANSION OF YOUR DEVICE SHELF-LIFE FROM 6 MONTHS TO 12 MONTHS.
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