PMA P950020S065
- Device
- CORONARY FLEXTOME CUTTING BALLON
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S065
- Product code
- MAF
- Decision date
- 2013-10-18
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- SOFTWARE CHANGES TO UPDATE THE MANUFACTURING EXECUTION SYSTEM.
Current openFDA PMA Record#
- Device
- CORONARY FLEXTOME CUTTING BALLON
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S065
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2013-10-18
- Decision code
- OK30
- Date received
- 2013-09-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- SOFTWARE CHANGES TO UPDATE THE MANUFACTURING EXECUTION SYSTEM.