|
Device | ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | BIOTRONIK, INC. 6024 JEAN ROAD LAKE OSWEGO, OR 97035 |
PMA Number | P160025 |
Date Received | 07/22/2016 |
Decision Date | 03/23/2017 |
Product Code |
NIP |
Docket Number | 17M-1845 |
Notice Date | 03/29/2017 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01319812
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Astron Pulsar Stent System and Pulsar-18 Stent System. These devices are indicated for use to improve luminal diameter in patients with symptomatic de novo, restenotic or occlusive lesions located in the superficial femoral or proximal popliteal arteries, with reference vessel diameters from 3.0 to 6.0mm and total lesion lengths up to 190mm. |
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 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 |