PMA P020009S122
- Device
- EXPRESS CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S122
- Product code
- MAF
- Decision date
- 2014-04-24
- Generic name
- STENT, CORONARY
- Approval order statement
- IMPLEMENT CHANGES THAT WILL OPTIMIZE THE RESIN DRYING PROCESS FOR THE CATHETER MANUFACTURE.
Current openFDA PMA Record#
- Device
- EXPRESS CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- PMA number
- P020009
- Supplement
- S122
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2014-04-24
- Decision code
- OK30
- Date received
- 2014-04-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENT CHANGES THAT WILL OPTIMIZE THE RESIN DRYING PROCESS FOR THE CATHETER MANUFACTURE.