PMA P070015S051
- Device
- XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P070015
- Supplement
- S051
- Product code
- NIQ
- Decision date
- 2010-11-08
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- INCREASE OF A RETESTING INTERVAL.
Current openFDA PMA Record#
- Device
- XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P070015
- Supplement
- S051
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2010-11-08
- Decision code
- OK30
- Date received
- 2010-10-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- INCREASE OF A RETESTING INTERVAL.