PMA P020009S118
- Device
- EXPRESS 2 MONORAIL AND OVER-THE-WIRE
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S118
- Product code
- MAF
- Decision date
- 2014-03-26
- Generic name
- STENT, CORONARY
- Approval order statement
- PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Current openFDA PMA Record#
- Device
- EXPRESS 2 MONORAIL AND OVER-THE-WIRE
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S118
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2014-03-26
- Decision code
- OK30
- Date received
- 2014-02-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM