PMA P950020S067
- Device
- FLEXTOME CUTTING BALLOON DILATATION DEVICE
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S067
- Product code
- MAF
- Decision date
- 2014-02-13
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- ADD A FIXTURE TO THE LASER USED IN THE HYPOTUBE-COREWIRE LASER BONDING STEP OF THE BALLOON CATHETER MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- FLEXTOME CUTTING BALLOON DILATATION DEVICE
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S067
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2014-02-13
- Decision code
- OK30
- Date received
- 2014-01-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD A FIXTURE TO THE LASER USED IN THE HYPOTUBE-COREWIRE LASER BONDING STEP OF THE BALLOON CATHETER MANUFACTURING PROCESS.