PMA P110019S090
- Device
- XIENCE V XIENCE nano Everolimus Eluting Coronary Stent System; XIENCE PRIMME /Xpedition Everolimus Eluting Coronary Sten
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S090
- Product code
- NIQ
- Decision date
- 2017-04-06
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Change to the balloon blow process parameters.
Current openFDA PMA Record#
- Device
- XIENCE V XIENCE nano Everolimus Eluting Coronary Stent System; XIENCE PRIMME /Xpedition Everolimus Eluting Coronary Sten
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S090
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2017-04-06
- Decision code
- OK30
- Date received
- 2017-03-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the balloon blow process parameters.