PMA P020009S121
- Device
- EXPRESS 2 MONORAIL AND OVER-THE-WIRE
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S121
- Product code
- MAF
- Decision date
- 2014-05-01
- Generic name
- STENT, CORONARY
- Approval order statement
- CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
Current openFDA PMA Record#
- Device
- EXPRESS 2 MONORAIL AND OVER-THE-WIRE
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S121
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2014-05-01
- Decision code
- OK30
- Date received
- 2014-03-31
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.