PMA P950020S040
- Device
- FLEXTOME CUTTING BALLOON
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S040
- Product code
- LOX
- Decision date
- 2011-01-07
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR A MODIFIED TEST METHOD AND SPECIFICATION EXTRACTABLES TESTING OF PEBAX RESIN MATERIAL.
Current openFDA PMA Record#
- Device
- FLEXTOME CUTTING BALLOON
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S040
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2011-01-07
- Decision code
- APPR
- Date received
- 2010-04-08
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MODIFIED TEST METHOD AND SPECIFICATION EXTRACTABLES TESTING OF PEBAX RESIN MATERIAL.