|
Device | PRESILLION PLUS COCR CORONARY STENT RX SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | MEDINOL LTD. KIRYAT ATIDIM, BLDG. 7 ENTRANCE A, P.O.B. 58165 TEL-AVIV 61581 |
PMA Number | P110004 |
Date Received | 02/09/2011 |
Decision Date | 04/12/2012 |
Withdrawal Date
|
11/02/2020 |
Product Code |
MAF |
Docket Number | 12M-0407 |
Notice Date | 05/01/2012 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE PRESILLION PLUS COCR CORONARY STENT ON RX SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE ASSOCIATED WITH STENOTIC LESIONS IN DE NOVO NATIVE CORONARY ARTERIES (LENGTH <= 30 MM) WITH A REFERENCE VESSEL DIAMETER OF 2.50 MM TO 4.00MM. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 |