PMA P030025S086
- Device
- TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
- Applicant
- Boston Scientific Corp
- PMA number
- P030025
- Supplement
- S086
- Product code
- NIQ
- Decision date
- 2012-02-22
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL TO EXPAND THE LABELED INDICATIONS FOR THE TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM. THE TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVING LUMINAL DIAMETER: 1) FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES 2.25 MM TO 4.00 MM IN DIAMETER IN LESIONS<= 28 MM IN LENGTH; 2) IN PATIENTS UNDERGOING PRIMARY ANGIOPLASTY TO TREAT ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, TRUE POSTERIOR MYOCARDIAL INFARCTION, OR PRESUMED NEW LEFT BUNDLE BRANCH BLOCK WITH SYMPTOMS OF ACUTE MYOCARDIAL INFARCTION LASTING > 20 MINUTES AND < 12 HOURS IN DURATION; OR 3) WITHIN BARE METAL STENT RESTENOTIC LESIONS 2.50 MM TO 3.75 MM IN DIAMETER AND <= 28 MM IN LENGTH.
Current openFDA PMA Record
- Device
- TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
- Applicant
- Boston Scientific Corp
- PMA number
- P030025
- Supplement
- S086
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2012-02-22
- Decision code
- APPR
- Date received
- 2010-03-08
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO EXPAND THE LABELED INDICATIONS FOR THE TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM. THE TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVING LUMINAL DIAMETER: 1) FOR THE TREATMENT OF DE NOVO LESIONS IN NATIVE CORONARY ARTERIES 2.25 MM TO 4.00 MM IN DIAMETER IN LESIONS 20 MINUTES AND < 12 HOURS IN DURATION; OR 3) WITHIN BARE METAL STENT RESTENOTIC LESIONS 2.50 MM TO 3.75 MM IN DIAMETER AND