PMA P950020S071
- Device
- FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S071
- Product code
- MAF
- Decision date
- 2015-02-04
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- UPDATE TO THE ADHESIVE MIXING SOFTWARE AND ASSOCIATED MANUFACTURING WORK INSTRUCTIONS.
Current openFDA PMA Record#
- Device
- FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S071
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2015-02-04
- Decision code
- OK30
- Date received
- 2015-01-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPDATE TO THE ADHESIVE MIXING SOFTWARE AND ASSOCIATED MANUFACTURING WORK INSTRUCTIONS.