PMA P950020S008
- Device
- CUTTING BALLOON ULTRA 2
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S008
- Product code
- LOX
- Decision date
- 2003-06-04
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR A TWO YEAR SHELF LIFE FOR BOTH THE OVER-THE-WIRE (OTW) AND MONORAIL (MR) DEVICES.
Current openFDA PMA Record#
- Device
- CUTTING BALLOON ULTRA 2
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S008
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2003-06-04
- Decision code
- APPR
- Date received
- 2003-03-21
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A TWO YEAR SHELF LIFE FOR BOTH THE OVER-THE-WIRE (OTW) AND MONORAIL (MR) DEVICES.