PMA P950020S024
- Device
- CUTTING BALLOON ULTRA2 MONORAIL (MR) PTCA CATHETER (CUTTING BALLOON)
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S024
- Product code
- LOX
- Decision date
- 2007-02-02
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- CHANGE IN THE STERILIZATION METHOD AS WELL AS A CHANGE IN DIMENSIONS OF THE OUTER SHIPPING BOX FOR THE CUTTING BALLOON.
Current openFDA PMA Record#
- Device
- CUTTING BALLOON ULTRA2 MONORAIL (MR) PTCA CATHETER (CUTTING BALLOON)
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S024
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2007-02-02
- Decision code
- OK30
- Date received
- 2007-01-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE STERILIZATION METHOD AS WELL AS A CHANGE IN DIMENSIONS OF THE OUTER SHIPPING BOX FOR THE CUTTING BALLOON.