PMA P950020S061
- Device
- FLEXTOME CORONARY CUTTING BALLOON
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S061
- Product code
- NIQ
- Decision date
- 2013-06-21
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL TO MANUFACTURE THE FLUSHING NEEDLE (ALSO KNOWN AS TIP BARRELL 30 GAUGE) ACCESSORY WITH AN ALTERNATIVE RESIN PROVIDED BY A NEW SUPPLIER.
Current openFDA PMA Record#
- Device
- FLEXTOME CORONARY CUTTING BALLOON
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S061
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2013-06-21
- Decision code
- APPR
- Date received
- 2013-03-29
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO MANUFACTURE THE FLUSHING NEEDLE (ALSO KNOWN AS TIP BARRELL 30 GAUGE) ACCESSORY WITH AN ALTERNATIVE RESIN PROVIDED BY A NEW SUPPLIER.