NIT-OCCLUD SYSTEM

Occluder, Patent Ductus, Arteriosus

FDA Premarket Approval P120009 S002

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

Addition of a new piece of equipment for a manufacturing process involving coiling of wire.

• Device: NIT-OCCLUD SYSTEM
• Classification Name: Occluder, Patent Ductus, Arteriosus
• Generic Name: Occluder, Patent Ductus, Arteriosus
• Applicant: PFM MEDICAL, INC
• Date Received: 2014-12-10
• Decision Date: 2015-01-21
• PMA: P120009
• Supplement: S002
• Product Code: MAE
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: PFM MEDICAL, INC 1916 Palomar Oaks Way suite 150 carlsbad, CA 92008

Supplemental Filings

Supplement Number	Date	Supplement Type
P120009		Original 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 ID	PMA	Supp
4042301160027	P120009	000
04042301159939	P120009	000
4042301160041	P120009	003
4042301160003	P120009	003
4042301159984	P120009	003
4042301159960	P120009	003