PMA P020009S116
- Device
- EXPRESS/EXPRESS2 MONORAIL AND OVER-THE-WIRE CONRONARY STENT SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S116
- Product code
- MAF
- Decision date
- 2014-02-06
- Generic name
- STENT, CORONARY
- Approval order statement
- REPLACEMENT OF A CAMERA IN THE CATHETER INSPECTION PROCESS.
Current openFDA PMA Record#
- Device
- EXPRESS/EXPRESS2 MONORAIL AND OVER-THE-WIRE CONRONARY STENT SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S116
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2014-02-06
- Decision code
- OK30
- Date received
- 2014-01-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REPLACEMENT OF A CAMERA IN THE CATHETER INSPECTION PROCESS.