3601 Medical Device User Fee Cover Sheet

Form Approved: OMB No. 0910-511 Expiration Date: February 28, 2013. See Instructions for OMB Statement.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
MEDICAL DEVICE USER FEE COVER SHEET

PAYMENT IDENTIFICATION NUMBER: MD6061131-956733
Write the Payment Identification number on your check.

A completed cover sheet must accompany each original application or supplement subject to fees. If payment is sent by U.S. mail or
courier, please include a copy of this completed form with payment. Payment and mailing instructions can be found at:
http://www.fda.gov/oc/mdufma/coversheet.html
1. COMPANY NAME AND ADDRESS (include name, street
address, city state, country, and post office code)

2. CONTACT NAME
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2.1 E-MAIL ADDRESS

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null null null
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1.1 EMPLOYER IDENTIFICATION NUMBER (EIN)

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2.2 TELEPHONE NUMBER (include Area code)
2.3 FACSIMILE (FAX) NUMBER (Include Area code)

3. TYPE OF PREMARKET APPLICATION (Select one of the following in each column; if you are unsure, please refer to the application
descriptions at the following web site: http://www.fda.gov/oc/mdufma
Select an application type:
3.1 Select a center
[ ] Premarket notification(510(k)); except for third party
[ ] CDRH
[ ] 513(g) Request for Information
[ ] CBER
[ ] Biologics License Application (BLA)
3.2 Select one of the types below
[ ] Premarket Approval Application (PMA)
[X] Original Application
[ ] Modular PMA
Supplement Types:
[ ] Product Development Protocol (PDP)
[ ] Efficacy (BLA)
[ ] Premarket Report (PMR)
[ ] Panel Track (PMA, PMR, PDP)
[ ] Annual Fee for Periodic Reporting (APR)
[ ] Real-Time (PMA, PMR, PDP)
[ ] 30-Day Notice
[ ] 180-day (PMA, PMR, PDP)
4. ARE YOU A SMALL BUSINESS? (See the instructions for more information on determining this status)
[ ] YES, I meet the small business criteria and have submitted the required
[X] NO, I am not a small business
qualifying documents to FDA
4.1 If Yes, please enter your Small Business Decision Number:
5. FDA WILL NOT ACCEPT YOUR SUBMISSION IF YOUR COMPANY HAS NOT PAID AN ESTABLISHMENT REGISTRATION FEE
THAT IS DUE TO FDA. HAS YOUR COMPANY PAID ALL ESTABLISHMENT REGISTRATION FEES THAT ARE DUE TO FDA?
[X] YES (All of our establishments have registered and paid the fee, or this is our first device, and we will register and pay the fee within
30 days of FDA's approval/clearance of this device.)
[ ] NO (If "NO," FDA will not accept your submission until you have paid all fees due to FDA. This submission will not be processed; see
http://www.fda.gov/cdrh/mdufma for additional information)
6. IS THIS PREMARKET APPLICATION COVERED BY ANY OF THE FOLLOWING USER FEE EXCEPTIONS? IF SO, CHECK THE
APPLICABLE EXCEPTION.
[ ] This application is the first PMA submitted by a qualified small business, [ ] The sole purpose of the application is to support
including any affiliates
conditions of use for a pediatric population
[ ] The application is submitted by a state or federal
[ ] This biologics application is submitted under section 351 of the Public
government entity for a device that is not to be distributed
Health Service Act for a product licensed for further manufacturing use only
commercially
7. IS THIS A SUPPLEMENT TO A PREMARKET APPLICATION FOR WHICH FEES WERE WAIVED DUE TO SOLE USE IN A
PEDIATRIC POPULATION THAT NOW PROPOSES CONDITION OF USE FOR ANY ADULT POPULATION? (If so, the application is
subject to the fee that applies for an original premarket approval application (PMA).
[ ] YES
[X] NO
PAPERWORK REDUCTION ACT STATEMENT
Public reporting burden for this collection of information is estimated to average 18 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for
reducing this burden, to the address below.
Department of Health and Human Services, Food and Drug Administration, Office of Chief Information Officer, 1350 Piccard Drive, 4th
Floor Rockville, MD 20850
[Please do NOT return this form to the above address, except as it pertains to comments on the burden estimate.]
8. USER FEE PAYMENT AMOUNT SUBMITTED FOR THIS PREMARKET APPLICATION
$0.00
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Form FDA 3601 (01/2007)

02-Apr-2012