PMA P030047S025
- Device
- PRECISE NITINOL STENT SYSTEM
- Applicant
- Cordis US Corporation
- PMA number
- P030047
- Supplement
- S025
- Product code
- NIM
- Decision date
- 2012-05-22
- Classification
- Stent, Carotid
- Generic name
- Stent, carotid
- Approval order statement
- CHANGES TO THE SEALING EQUIPMENT AND ADDITIONS TO IMPROVE THE VISUAL INSPECTION PROCESS.
Current openFDA PMA Record#
- Device
- PRECISE NITINOL STENT SYSTEM
- Applicant
- Cordis US Corporation
- PMA number
- P030047
- Supplement
- S025
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2012-05-22
- Decision code
- OK30
- Date received
- 2012-04-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE SEALING EQUIPMENT AND ADDITIONS TO IMPROVE THE VISUAL INSPECTION PROCESS.