Permacol P152050

GUDID 10884523000221

Surgical Implant

SOFRADIM PRODUCTION

Extra-gynaecological surgical mesh, collagen, bioabsorbable
Primary Device ID10884523000221
NIH Device Record Key502bab0c-43db-41e7-b4c6-75489f26b8bc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePermacol
Version Model NumberP152050
Catalog NumberP152050
Company DUNS576342646
Company NameSOFRADIM PRODUCTION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter
Depth1.5 Millimeter
Width20 Centimeter
Length50 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *;
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *;
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *;
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *;
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *;
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *;
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit
Handling Environment TemperatureBetween 36 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110884523000221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTMMesh, surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-06-10
Device Publish Date2015-10-22

On-Brand Devices [Permacol]

10884523000573Collagen Repair Patch
10884523000566Collagen Repair Patch
10884523000153Surgical Implant
10884523000146Surgical Implant
10884523000238Surgical Implant
10884523000214Surgical Implant
10884523000177Surgical Implant
10884523000160Surgical Implant
10884523000139Surgical Implant
10884523000122Surgical Implant
10884523000115Surgical Implant
10884523000108Surgical Implant
10884523000092Surgical Implant
10884523000085Surgical Implant
10884523000078Surgical Implant
10884523000061Surgical Implant
10884523000054Surgical Implant
10884523000047Surgical Implant
10884523000023Surgical Implant
10884523000245Surgical Implant
10884523000221Surgical Implant
10884523000207Surgical Implant
10884523000191Surgical Implant
10884523000184Surgical Implant
10884523000016Surgical Implant

Trademark Results [Permacol]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PERMACOL
PERMACOL
76405739 2780496 Dead/Cancelled
Paul Hartmann AG
2002-05-10
PERMACOL
PERMACOL
75587937 2654649 Live/Registered
COVIDIEN AG
1998-11-13
PERMACOL
PERMACOL
72015862 0648764 Dead/Expired
W. H. & L. D. BETZ (PARTNERSHIP)
1956-09-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.