PMA P100023S056
- Device
- ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S056
- Product code
- NIQ
- Decision date
- 2012-11-05
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- MANUFACTURING SOFTWARE CHANGES PERTAINING TO THE CATHETERS.
Current openFDA PMA Record
- Device
- ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S056
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2012-11-05
- Decision code
- OK30
- Date received
- 2012-10-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING SOFTWARE CHANGES PERTAINING TO THE CATHETERS.