PMA P020009S115
- Device
- EXPRESS 2 MONORAIL AND OVER THE WIRE
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S115
- Product code
- MAF
- Decision date
- 2014-02-13
- Generic name
- STENT, CORONARY
- Approval order statement
- EQUIPMENT CHANGE TO ONE OF THE ETHYLENE OXIDE STERILIZATION CHAMBERS.
Current openFDA PMA Record#
- Device
- EXPRESS 2 MONORAIL AND OVER THE WIRE
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S115
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2014-02-13
- Decision code
- OK30
- Date received
- 2014-01-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- EQUIPMENT CHANGE TO ONE OF THE ETHYLENE OXIDE STERILIZATION CHAMBERS.