FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM

FDA Premarket Approval P100028 S004

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a labeling update based on the post-approval study results.

DeviceFORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
Generic NameStent, Renal
ApplicantCOOK MEDICAL INCORPORATED
Date Received2013-09-20
Decision Date2014-10-08
PMAP100028
SupplementS004
Product CodeNIN 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination Product No
Applicant Address COOK MEDICAL INCORPORATED 750 Daniels Way p.o. Box 489 bloomington, IN 47402-0489

Supplemental Filings

Supplement NumberDateSupplement Type
P100028Original Filing
S004 2013-09-20 Normal 180 Day Track No User Fee
S003 2013-01-28 Normal 180 Day Track
S002 2012-02-13 Real-time Process
S001 2011-10-06 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
10827002569758 P100028 001
10827002569628 P100028 001
10827002569611 P100028 001
10827002569604 P100028 001
10827002569598 P100028 001
10827002569581 P100028 001
10827002185286 P100028 001
10827002185279 P100028 001
10827002185262 P100028 001
10827002185255 P100028 001
10827002185248 P100028 001
10827002569635 P100028 001
10827002569642 P100028 001
10827002569741 P100028 001
10827002569734 P100028 001
10827002569727 P100028 001
10827002569710 P100028 001
10827002569703 P100028 001
10827002569697 P100028 001
10827002569680 P100028 001
10827002569673 P100028 001
10827002569666 P100028 001
10827002569659 P100028 001
10827002185231 P100028 001

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