PMA P020026S081
- Device
- CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER
- Applicant
- Cordis Corp.
- PMA number
- P020026
- Supplement
- S081
- Product code
- NIQ
- Decision date
- 2011-03-03
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR AUTOMATION OF YOUR STENT COATING PROCESS.
Current openFDA PMA Record#
- Device
- CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (CYPHER
- Applicant
- Cordis Corp.
- PMA number
- P020026
- Supplement
- S081
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2011-03-03
- Decision code
- APPR
- Date received
- 2010-09-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AUTOMATION OF YOUR STENT COATING PROCESS.