Zilver PTX Drug-Eluting Peripheral Stent
FDA premarket approval P100022/S036 · decided 2020-07-31
Approval details
- PMA number
- P100022
- Supplement
- S036
- 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
- 2020-07-02
- Decision date
- 2020-07-31
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- Change to raw drug substance expiry and retest period.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.