PMA P100023S104
- Device
- ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM- MONORAIL AND ION PACLITAXEL-ELUTING CORONAY STENT SYSTEM- OVER THE WIRE
- Applicant
- Boston Scientific Corp.
- PMA number
- P100023
- Supplement
- S104
- Product code
- NIQ
- Decision date
- 2015-01-21
- Generic name
- Coronary Drug-eluting Stent
- Approval order statement
- APPROVAL FOR A REVISED LABELING UPDATE FOR THE TAXUS PERSEUS WORKHORSE (WH) AND SMALL VESSEL (SV) 5-YEAR STUDY PER POST-APPROVAL COMMITMENT #1.
Current openFDA PMA Record
- Device
- ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM- MONORAIL AND ION PACLITAXEL-ELUTING CORONAY STENT SYSTEM- OVER THE WIRE
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S104
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2015-01-21
- Decision code
- APPR
- Date received
- 2014-08-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR A REVISED LABELING UPDATE FOR THE TAXUS PERSEUS WORKHORSE (WH) AND SMALL VESSEL (SV) 5-YEAR STUDY PER POST-APPROVAL COMMITMENT #1.