PMA P020009
- Device
- EXPRESS 2 MR & OTW
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S128
- Product code
- MAF
- Decision date
- 2016-08-10
- Generic name
- STENT, CORONARY
- Approval order statement
- Sterilize the devices with the optimized BSC2000-2 cycle in Chamber 5 and Chamber 7 at BSC Coventry, Rhode Island.
Current openFDA PMA Record#
- Device
- EXPRESS 2 MR & OTW
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S128
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2016-08-10
- Decision code
- OK30
- Date received
- 2016-07-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Sterilize the devices with the optimized BSC2000-2 cycle in Chamber 5 and Chamber 7 at BSC Coventry, Rhode Island.