Cordis® PALMAZ® Balloon-Expandable Stent
FDA premarket approval P890017/S023 · decided 2022-12-20
Approval details
- PMA number
- P890017
- Supplement
- S023
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Cordis® PALMAZ® Balloon-Expandable Stent
- Generic name
- STENT, ILIAC
- Applicant
- Cordis US Corporation
- Date received
- 2022-09-28
- Decision date
- 2022-12-20
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval to remove references to obsoleted accessory devices and add instructions for unaided manual crimping of the stent implant to a stent delivery system (i.e., balloon catheter) in the Instructions For Use (IFU) document.
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