PMA P100023S082
- Device
- ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE WIRE SYSTEMS)
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S082
- Product code
- NIQ
- Decision date
- 2013-12-18
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- CHANGE TO IMPLEMENT A LASERLINC MEASUREMENT SYSTEM FOR MEASURING AND SORTING EXTRUDED COMPONENTS.
Current openFDA PMA Record
- Device
- ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE WIRE SYSTEMS)
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S082
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2013-12-18
- Decision code
- OK30
- Date received
- 2013-11-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO IMPLEMENT A LASERLINC MEASUREMENT SYSTEM FOR MEASURING AND SORTING EXTRUDED COMPONENTS.