PMA P100023S030
- Device
- ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S030
- Product code
- NIQ
- Decision date
- 2012-04-05
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR VARIOUS CYCLE TIME REDUCTIONS.
Current openFDA PMA Record
- Device
- ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S030
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2012-04-05
- Decision code
- APPR
- Date received
- 2011-12-23
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR VARIOUS CYCLE TIME REDUCTIONS.