PMA P070015S093
- Device
- XIENCE AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P070015
- Supplement
- S093
- Product code
- NIQ
- Decision date
- 2013-02-01
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR MODIFICATION OF A DRUG RELEASE PROFILE TEST METHOD.
Current openFDA PMA Record#
- Device
- XIENCE AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P070015
- Supplement
- S093
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2013-02-01
- Decision code
- APPR
- Date received
- 2012-05-14
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR MODIFICATION OF A DRUG RELEASE PROFILE TEST METHOD.