PMA P030047S034
- Device
- Cordis Precise Nitinol Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P030047
- Supplement
- S034
- Product code
- NIM
- Decision date
- 2017-12-15
- Classification
- Stent, Carotid
- Generic name
- Stent, carotid
- Approval order statement
- Tighten a specification and add an in-process test.
Current openFDA PMA Record#
- Device
- Cordis Precise Nitinol Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P030047
- Supplement
- S034
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2017-12-15
- Decision code
- OK30
- Date received
- 2017-11-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Tighten a specification and add an in-process test.