PMA P070015S081
- Device
- XIENCE V, PROMUS & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P070015
- Supplement
- S081
- Product code
- NIQ
- Decision date
- 2011-10-28
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- AUTOMATED PROCESS FOR PREPARATION OF THE ADAPTION CUP.
Current openFDA PMA Record#
- Device
- XIENCE V, PROMUS & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P070015
- Supplement
- S081
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2011-10-28
- Decision code
- OK30
- Date received
- 2011-10-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- AUTOMATED PROCESS FOR PREPARATION OF THE ADAPTION CUP.