PMA P020009S123
- Device
- EXPRESS2 CORONARY STENT SYSTEM (MONORAIL AND OVER THE WIRE)
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S123
- Product code
- MAF
- Decision date
- 2014-10-10
- Generic name
- STENT, CORONARY
- Approval order statement
- APPROVAL FOR A SOFTWARE UPGRADE TO UPDATE THE RADIO FREQUENCY IDENTIFICATION (RFID) READING SOFTWARE.
Current openFDA PMA Record#
- Device
- EXPRESS2 CORONARY STENT SYSTEM (MONORAIL AND OVER THE WIRE)
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S123
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2014-10-10
- Decision code
- APPR
- Date received
- 2014-04-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A SOFTWARE UPGRADE TO UPDATE THE RADIO FREQUENCY IDENTIFICATION (RFID) READING SOFTWARE.