PMA P100023S112
- Device
- ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp.
- PMA number
- P100023
- Supplement
- S112
- Product code
- NIQ
- Decision date
- 2015-01-14
- Generic name
- Coronary Drug-eluting Stent
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN MAPLE GROVE, MINNESOTA.
Current openFDA PMA Record
- Device
- ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S112
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2015-01-14
- Decision code
- APPR
- Date received
- 2014-12-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN MAPLE GROVE, MINNESOTA.