|
Device | ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM |
Generic Name | Absorbable coronary drug-eluting stent |
Applicant | ABBOTT VASCULAR INC. 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P150023 |
Date Received | 07/01/2015 |
Decision Date | 07/05/2016 |
Withdrawal Date
|
05/11/2023 |
Product Code |
PNY |
Docket Number | 16M-1914 |
Notice Date | 07/21/2016 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00856856
|
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) System. This device is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions >=2.5 mm to <=3.75 mm in diameter in lesions <=24 mm in length. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S005 S006 S007 S008 S009 S010 |