PMA P950020S038
- Device
- FLEXTOME CUTTING BALLOON DILATATIONS DEVICE
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S038
- Product code
- LOX
- Decision date
- 2010-02-22
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- CHANGE TO INCOMING ACCEPTANCE TEST METHODS.
Current openFDA PMA Record#
- Device
- FLEXTOME CUTTING BALLOON DILATATIONS DEVICE
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S038
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2010-02-22
- Decision code
- OK30
- Date received
- 2010-01-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO INCOMING ACCEPTANCE TEST METHODS.