PMA P100023S097
- Device
- ION PACLITAXEL-ELUTING PLATNIUM CHROMIUM CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S097
- Product code
- NIQ
- Decision date
- 2014-05-22
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- CHANGE TO USE A COLOR CAMERA FOR THE DISTAL TIP INSPECTION PROCESS.
Current openFDA PMA Record
- Device
- ION PACLITAXEL-ELUTING PLATNIUM CHROMIUM CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S097
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2014-05-22
- Decision code
- OK30
- Date received
- 2014-04-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO USE A COLOR CAMERA FOR THE DISTAL TIP INSPECTION PROCESS.