PMA P020037
- Device
- FX MINIRAIL RX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
- Applicant
- ABBOTT VASCULAR INC.
- PMA number
- P020037
- Product code
- LOX
- Decision date
- 2003-06-11
- Generic name
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Approval order statement
- APPROVAL FOR THE FX MINIRAIL TX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER. THE DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY, INCLUDING IN-STENT RESTENOSIS, FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
- Summary
- Summary of Safety and Effectiveness
Current openFDA PMA Record
- Device
- FX MINIRAIL PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P020037
- Supplement
- S002
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2008-01-11
- Decision code
- OK30
- Date received
- 2007-12-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN A QUALITY CONTROL TEST USED TO DETERMINE A SPECIFIC ATTRIBUTE OF THE IN PROCESS DEVICE.