PMA P020009S125
- Device
- EXPRESS 2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S125
- Product code
- MAF
- Decision date
- 2014-12-08
- Generic name
- STENT, CORONARY
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH IN ALAJUELA, COSTA RICA.
Current openFDA PMA Record#
- Device
- EXPRESS 2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S125
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2014-12-08
- Decision code
- APPR
- Date received
- 2014-06-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH IN ALAJUELA, COSTA RICA.