PMA P100023S098
- Device
- ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp.
- PMA number
- P100023
- Supplement
- S098
- Product code
- NIQ
- Decision date
- 2014-10-10
- Generic name
- Coronary Drug-eluting Stent
- Approval order statement
- APPROVAL FOR A SOFTWARE UPGRADE TO UPDATE THE RADIO FREQUENCY IDENTIFICATION (RFID) READING SOFTWARE.
Current openFDA PMA Record
- Device
- ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S098
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2014-10-10
- Decision code
- APPR
- Date received
- 2014-04-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A SOFTWARE UPGRADE TO UPDATE THE RADIO FREQUENCY IDENTIFICATION (RFID) READING SOFTWARE.