PMA P100023S003
- Device
- ION (TAXUS ELEMENT) PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL) & OTW
- Applicant
- Boston Scientific Corp.
- PMA number
- P100023
- Supplement
- S003
- Product code
- NIQ
- Decision date
- 2011-12-15
- Generic name
- Coronary Drug-eluting Stent
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record
- Device
- ION (TAXUS ELEMENT) PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL) & OTW
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S003
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2011-12-15
- Decision code
- APPR
- Date received
- 2011-05-04
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.