PMA P100023S100
- Device
- ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S100
- Product code
- NIQ
- Decision date
- 2014-06-04
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- REMOVE THE MANUAL INSPECTION OF THE DISTANCE BETWEEN THE BI-COMPONENT ASSEMBLY (BOND) AND PROXIMAL BALLOON BOND.
Current openFDA PMA Record
- Device
- ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S100
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2014-06-04
- Decision code
- OK30
- Date received
- 2014-05-05
- Supplement type
- 30-Day Notice
- Approval order statement
- REMOVE THE MANUAL INSPECTION OF THE DISTANCE BETWEEN THE BI-COMPONENT ASSEMBLY (BOND) AND PROXIMAL BALLOON BOND.