PMA NIT-OCCLUD PDA

Occluder, Patent Ductus, Arteriosus

FDA Premarket Approval P120009 S003

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 of the revised protocol for the post-approval study (pas) protocol.

DevicePMA NIT-OCCLUD PDA
Classification NameOccluder, Patent Ductus, Arteriosus
Generic NameOccluder, Patent Ductus, Arteriosus
ApplicantPFM MEDICAL, INC
Date Received2016-10-12
Decision Date2016-12-16
PMAP120009
SupplementS003
Product CodeMAE
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Osb
Expedited ReviewNo
Combination Product No
Applicant Address PFM MEDICAL, INC 1916 Palomar Oaks Way suite 150 carlsbad, CA 92008

Supplemental Filings

Supplement NumberDateSupplement Type
P120009Original Filing
S003 2016-10-12 Normal 180 Day Track No User Fee
S002 2014-12-10 30-day Notice
S001 2014-05-05 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
4042301160027 P120009 000
04042301159939 P120009 000
4042301160041 P120009 003
4042301160003 P120009 003
4042301159984 P120009 003
4042301159960 P120009 003

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