PMA P860019S208
- Device
- APEX MONORAIL AND OVER-THE-WIRE PTCA DILATATION CATHETERS
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S208
- Product code
- LOX
- Decision date
- 2008-11-07
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR THE APEX MONORAIL AND OVER-THE-WIRE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS. THE DEVICE, AS MODIFIED, IS INDICATED FOR: 1) (BALLOON MODELS 1.5 ¿ 5.0 MM) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION; AND 2) (BALLOON MODELS 2.0 ¿ 5.0 MM) FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.
Current openFDA PMA Record#
- Device
- APEX MONORAIL AND OVER-THE-WIRE PTCA DILATATION CATHETERS
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S208
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2008-11-07
- Decision code
- APPR
- Date received
- 2006-04-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE APEX MONORAIL AND OVER-THE-WIRE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS. THE DEVICE, AS MODIFIED, IS INDICATED FOR: 1) (BALLOON MODELS 1.5 ¿ 5.0 MM) BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION; AND 2) (BALLOON MODELS 2.0 ¿ 5.0 MM) FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.