PMA P950020S001
- Device
- CUTTING BALLOON
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S001
- Product code
- LOX
- Decision date
- 2000-11-21
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE DISTAL TIP OF THE CUTTING BALLOON(TM).
Current openFDA PMA Record#
- Device
- CUTTING BALLOON
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S001
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2000-11-21
- Decision code
- APPR
- Date received
- 2000-10-17
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE DISTAL TIP OF THE CUTTING BALLOON(TM).