PMA P950020S046
- Device
- CUTTING BALLOON ULTRA 2 MONORAIL AND FLEXTOME CUTTING BALLOON MONORAIL
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S046
- Decision date
- 2011-08-04
- Approval order statement
- CHANGE TO THE INFLATION MANIFOLD COMPONENT INSPECTION PROCESS.
Current openFDA PMA Record#
- Device
- CUTTING BALLOON ULTRA 2 MONORAIL AND FLEXTOME CUTTING BALLOON MONORAIL
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S046
- Decision date
- 2011-08-04
- Decision code
- OK30
- Date received
- 2011-07-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE INFLATION MANIFOLD COMPONENT INSPECTION PROCESS.