PMA P020009S119
- Device
- EXPRESS MONORAIL AND OTW CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S119
- Product code
- MAF
- Decision date
- 2014-03-25
- Generic name
- STENT, CORONARY
- Approval order statement
- ADD TWO ADDITIONAL INDIVIDUAL MOLDING STATION (IMS) BALLOON MOLDING TOWERS IN THE BALLOONS PRODUCTION AREA AT THE MAPLE GROVE FACILITY.
Current openFDA PMA Record#
- Device
- EXPRESS MONORAIL AND OTW CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S119
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2014-03-25
- Decision code
- OK30
- Date received
- 2014-02-25
- Supplement type
- 30-Day Notice
- Approval order statement
- ADD TWO ADDITIONAL INDIVIDUAL MOLDING STATION (IMS) BALLOON MOLDING TOWERS IN THE BALLOONS PRODUCTION AREA AT THE MAPLE GROVE FACILITY.