PMA P110019S085
- Device
- XIENCE V NANO, XIENCE PRIME XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM; HI-TORQUE PROGRESS, PILOT GUIDE
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S085
- Product code
- NIQ
- Decision date
- 2017-03-03
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Approval for changes to the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- XIENCE V NANO, XIENCE PRIME XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM; HI-TORQUE PROGRESS, PILOT GUIDE
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S085
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2017-03-03
- Decision code
- APPR
- Date received
- 2016-07-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval for changes to the protocol for the post-approval study (PAS) protocol.