PMA P110019S084
- Device
- XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S084
- Product code
- NIQ
- Decision date
- 2016-04-15
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Change the sampling plan for annual stability of the repackaged drug substance.
Current openFDA PMA Record#
- Device
- XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110019
- Supplement
- S084
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2016-04-15
- Decision code
- OK30
- Date received
- 2016-03-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the sampling plan for annual stability of the repackaged drug substance.