PMA P100023S070
- Device
- ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp.
- PMA number
- P100023
- Supplement
- S070
- Product code
- NIQ
- Decision date
- 2013-03-05
- Generic name
- Coronary Drug-eluting Stent
- Approval order statement
- REMOVAL OF A REDUNDANT OFF-LINE INSPECTION FOR EXTRUDED COMPONENTS USED TO MANUFACTURE THE ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM.
Current openFDA PMA Record
- Device
- ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S070
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2013-03-05
- Decision code
- OK30
- Date received
- 2013-02-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REMOVAL OF A REDUNDANT OFF-LINE INSPECTION FOR EXTRUDED COMPONENTS USED TO MANUFACTURE THE ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM.