PMA P890017S017
- Device
- CORDIS PALMAZ BALLOON-EXPANDABLE STENT
- Applicant
- Cordis US Corporation
- PMA number
- P890017
- Supplement
- S017
- Product code
- NIN
- Decision date
- 2016-07-18
- Classification
- Stent, Renal
- Generic name
- STENT, RENAL
- Approval order statement
- Approval for a change of the type of dosimeter used during routine sterilization dose auditing.
Current openFDA PMA Record#
- Device
- CORDIS PALMAZ BALLOON-EXPANDABLE STENT
- Applicant
- Cordis US Corporation
- PMA number
- P890017
- Supplement
- S017
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2016-07-18
- Decision code
- APPR
- Date received
- 2015-06-24
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change of the type of dosimeter used during routine sterilization dose auditing.