- Device
- CORONARY FLEXTOME CUTTING BALLOON DEVICE
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S032
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2009-04-13
- Decision code
- APPR
- Date received
- 2009-03-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT ISOTRON PLC, DAVENTRY, UNITED KINGDOM FOR RADIATION STERILIZATION.