PMA P890017S016
- Device
- CORDIS PALMAZ BALLOON-EXPANDABLE STENT
- Applicant
- Cordis US Corporation
- PMA number
- P890017
- Supplement
- S016
- Product code
- NIN
- Decision date
- 2015-04-16
- Classification
- Stent, Renal
- Generic name
- STENT, RENAL
- Approval order statement
- REPLACE MANUFACTURING EQUIPMENT USED TO SEAL THE PRODUCT PACKAGING WITH AN UPDATED MODEL.
Current openFDA PMA Record#
- Device
- CORDIS PALMAZ BALLOON-EXPANDABLE STENT
- Applicant
- Cordis US Corporation
- PMA number
- P890017
- Supplement
- S016
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2015-04-16
- Decision code
- OK30
- Date received
- 2015-03-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACE MANUFACTURING EQUIPMENT USED TO SEAL THE PRODUCT PACKAGING WITH AN UPDATED MODEL.