Cordis® PALMAZ® Balloon-Expandable Stent
FDA premarket approval P890017/S022 · decided 2022-03-08
Approval details
- PMA number
- P890017
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Cordis® PALMAZ® Balloon-Expandable Stent
- Generic name
- STENT, RENAL
- Applicant
- Cordis US Corporation
- Date received
- 2021-12-08
- Decision date
- 2022-03-08
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NIN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval for updates to the MRI section in the Palmaz labeling and other minor labeling updates.
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