PMA P040016S126
- Device
- VERIFLEX (LIBERTE) CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P040016
- Supplement
- S126
- Product code
- MAF
- Decision date
- 2014-04-23
- Generic name
- STENT, CORONARY
- Approval order statement
- CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.
Current openFDA PMA Record#
- Device
- VERIFLEX (LIBERTE) CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P040016
- Supplement
- S126
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2014-04-23
- Decision code
- OK30
- Date received
- 2014-03-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO ADD A NEW ETHYLENE OXIDE STERILIZATION CHAMBER.