PMA P100023S062
- Device
- ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S062
- Product code
- NIQ
- Decision date
- 2012-11-23
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- SOFTWARE UPGRADE TO THE VISICON INSPECTION SYSTEM.
Current openFDA PMA Record
- Device
- ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S062
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2012-11-23
- Decision code
- OK30
- Date received
- 2012-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- SOFTWARE UPGRADE TO THE VISICON INSPECTION SYSTEM.