PMA P890017S022
- Device
- Cordis® PALMAZ® Balloon-Expandable Stent
- Applicant
- Cordis US Corporation
- PMA number
- P890017
- Supplement
- S022
- Product code
- NIN
- Decision date
- 2022-03-08
- Generic name
- STENT, RENAL
- Approval order statement
- Approval for updates to the MRI section in the Palmaz labeling and other minor labeling updates.
Current openFDA PMA Record#
- Device
- Cordis® PALMAZ® Balloon-Expandable Stent
- Applicant
- Cordis US Corporation
- PMA number
- P890017
- Supplement
- S022
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2022-03-08
- Decision code
- APPR
- Date received
- 2021-12-08
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updates to the MRI section in the Palmaz labeling and other minor labeling updates.