PMA P860019S227
- Device
- QUANTUM MAVERICK MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S227
- Product code
- LOX
- Decision date
- 2008-10-08
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR MODIFICATION TO THE PROXIMAL WELD PROCESS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUANTUM MAVERICK BALLOON CATHETERS AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE QUANTUM MAVERICK BALLOON CATHETER (BALLOON MODELS 2.0 MM ¿ 5.0 MM) IS ALSO INDICATED FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.
Current openFDA PMA Record#
- Device
- QUANTUM MAVERICK MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S227
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2008-10-08
- Decision code
- APPR
- Date received
- 2008-08-12
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR MODIFICATION TO THE PROXIMAL WELD PROCESS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUANTUM MAVERICK BALLOON CATHETERS AND IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE QUANTUM MAVERICK BALLOON CATHETER (BALLOON MODELS 2.0 MM ¿ 5.0 MM) IS ALSO INDICATED FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS.