PMA P950020S010
- Device
- FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S010
- Product code
- LIT
- Decision date
- 2005-07-18
- Classification
- Catheter, Angioplasty, Peripheral, Transluminal
- Generic name
- Catheter, angioplasty, peripheral, transluminal
- Approval order statement
- APPROVAL FOR DESIGN, MANUFACTURING, AND LABELING CHANGES IN THE CUTTING BALLOON, BOTH OVER-THE-WIRE (OTW) AND MONORAIL (MR) CONFIGURATIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLEXTOME CUTTING BALLOON AND IS INDICATED FOR DILATATION OF STENOSES IN CORONARY ARTERIES FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION IN THOSE CIRCUMSTANCES WHERE A HIGH PRESSURE BALLOON RESISTANT LESION IS ENCOUNTERED.
Current openFDA PMA Record#
- Device
- FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S010
- Product code
- LIT
- Generic name
- Catheter, angioplasty, peripheral, transluminal
- Decision date
- 2005-07-18
- Decision code
- APPR
- Date received
- 2004-09-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR DESIGN, MANUFACTURING, AND LABELING CHANGES IN THE CUTTING BALLOON, BOTH OVER-THE-WIRE (OTW) AND MONORAIL (MR) CONFIGURATIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLEXTOME CUTTING BALLOON AND IS INDICATED FOR DILATATION OF STENOSES IN CORONARY ARTERIES FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION IN THOSE CIRCUMSTANCES WHERE A HIGH PRESSURE BALLOON RESISTANT LESION IS ENCOUNTERED.