PMA P950020S039
- Device
- CORONARY FLEXTOME CUTTING BALLOON
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S039
- Product code
- LOX
- Decision date
- 2010-04-06
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- IMPLEMENTATION OF A NEW COATING PROCESS FOR MANDRELS.
Current openFDA PMA Record#
- Device
- CORONARY FLEXTOME CUTTING BALLOON
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S039
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2010-04-06
- Decision code
- OK30
- Date received
- 2010-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF A NEW COATING PROCESS FOR MANDRELS.