PMA P110019S018

Device: XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S018
Product code: NIQ
Decision date: 2012-10-05
Classification: Coronary Drug-eluting Stent
Generic name: Coronary drug-eluting stent
Approval order statement: APPROVAL TO ALLOW THE CORRESPONDING DRUG CONTENT VALUES TO BE CENTERED AROUND 100% LABEL CLAIM AND PROVIDE INCREASED PROBABILITY THAT INDIVIDUAL UNITS WILL HAVE A DRUG CONTENT OF GREATER THAN 90% OF THE LABELED CLAIM TO MEET THE CONDITION OF APPROVAL THAT "WITHIN 12 MONTHS OF PMA APPROVAL, YOU SHOULD SUBMIT A PMA SUPPLEMENT REQUESTING APPROVAL TO TIGHTEN THE IN-PROCESS COATING WEIGHT GAIN SPECIFICATION OR IMPLEMENT PROCEDURES TO RE-COAT STENTS WITH LESS THAN 95% COATING WEIGHT GAIN UPON IN-PROCESS INSPECTION. THE COMPANY HAS PROVIDED THE ALTERNATIVE SOLUTION.

Current openFDA PMA Record#

Device: XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Applicant: Abbott Vascular
PMA number: P110019
Supplement: S018
Product code: NIQ
Generic name: Coronary drug-eluting stent
Decision date: 2012-10-05
Decision code: APPR
Date received: 2012-05-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO ALLOW THE CORRESPONDING DRUG CONTENT VALUES TO BE CENTERED AROUND 100% LABEL CLAIM AND PROVIDE INCREASED PROBABILITY THAT INDIVIDUAL UNITS WILL HAVE A DRUG CONTENT OF GREATER THAN 90% OF THE LABELED CLAIM TO MEET THE CONDITION OF APPROVAL THAT "WITHIN 12 MONTHS OF PMA APPROVAL, YOU SHOULD SUBMIT A PMA SUPPLEMENT REQUESTING APPROVAL TO TIGHTEN THE IN-PROCESS COATING WEIGHT GAIN SPECIFICATION OR IMPLEMENT PROCEDURES TO RE-COAT STENTS WITH LESS THAN 95% COATING WEIGHT GAIN UPON IN-PROCESS INSPECTION. THE COMPANY HAS PROVIDED THE ALTERNATIVE SOLUTION.