PMA P100023S015
- Device
- ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
- Applicant
- Boston Scientific Corp.
- PMA number
- P100023
- Supplement
- S015
- 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 ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE). THE ION 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.
- Summary
- Summary of Safety and Effectiveness
Current openFDA PMA Record
- Device
- ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
- Applicant
- Boston Scientific Corp
- PMA number
- P100023
- Supplement
- S015
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2012-02-22
- Decision code
- APPR
- Date received
- 2011-07-15
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO EXPAND THE LABELED INDICATIONS FOR THE ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE). THE ION 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.