PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM

Stent, Coronary

FDA Premarket Approval P160003

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the pro-kinetic energy cobalt chromium (cocr) coronary stent system. This device is indicated for improving coronary luminal diameter in patients with de novo or restenotic lesions in native coronary arteries with a reference vessel diameter ranging from 2. 25 mm to 4. 0 mm and lesion length

DevicePRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM
Classification NameStent, Coronary
Generic NameStent, Coronary
ApplicantBIOTRONIK, INC.
Date Received2016-01-19
Decision Date2017-02-14
Notice Date2017-02-17
PMAP160003
SupplementS
Product CodeMAF
Docket Number16M-2652
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P160003Original Filing
S015 2022-06-21 30-day Notice
S014 2021-06-14 30-day Notice
S013 2021-04-08 30-day Notice
S012 2021-03-25 30-day Notice
S011
S010 2020-07-09 30-day Notice
S009 2019-11-04 30-day Notice
S008 2019-05-06 30-day Notice
S007
S006 2018-06-29 135 Review Track For 30-day Notice
S005 2018-05-10 Normal 180 Day Track No User Fee
S004 2018-04-16 30-day Notice
S003
S002 2017-04-19 135 Review Track For 30-day Notice
S001 2017-02-22 30-day Notice

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