- Device
- MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)
- Applicant
- Abbott Vascular Devices
- PMA number
- P910031
- Supplement
- S023
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2006-02-16
- Decision code
- APPR
- Date received
- 2004-11-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW). THE MERLIN PTCA CATHETER (OTW) IS INDICATED FOR USE IN BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE NC MERLIN PTCA CATHETER (OTW) IS INDICATED FOR USE IN BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION, AND FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.