Andrea Mitchell

FDA Filings

This page includes the latest FDA filings for Andrea Mitchell. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3013060098
• FEI Number: 3013060098
• Name: Andrea Mitchell
• Owner & Operator: Medtronic
• Contact Address: 16720 Trans-Canada, Suite 200 ; Kirkland CA-QC Quebec H9H 4M7 CA
• US Agent:
  • Andrea Mitchell
  • 508 2616327
  • andrea.l.mitchell@medtronic.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 15 Hampshire Street ; Mansfield, MA 02048 US
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

• Registration Number: 9710107
• FEI Number: 3003348376
• Name: Andrea Mitchell
• Owner & Operator: Given Imaging Inc.
• Contact Address: 2 Hacarmel St., New Industrial Park, POB ; Yoqneam IL-Z Ha Zafon 20692 IL
• Official Correspondent:
  • Hilla - Debby
  • 972-4-9097774-x
• US Agent:
  • Andrea Mitchell
  • 508 2616327
  • andrea.l.mitchell@medtronic.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 15 Hampshire Street ; Mansfield, MA 02048 US
• Establishment Type:
  • Remanufacture Medical Device
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K183453 | OWN Andrea Mitchell [Given Imaging Inc.]	VS3 Iridium 785nm (VS3-IR-785) including MMS-IR and Endoscope-IR	2020-02-26
PMN K183453 | HRX Andrea Mitchell [Given Imaging Inc.]	VS3 Iridium 785nm (VS3-IR-785) including MMS-IR and Endoscope-IR	2020-02-26
PMN K183453 | GWG Andrea Mitchell [Given Imaging Inc.]	VS3 Iridium 785nm (VS3-IR-785) including MMS-IR and Endoscope-IR	2020-02-26
PMN K183453 | GCJ Andrea Mitchell [Given Imaging Inc.]	VS3 Iridium 785nm (VS3-IR-785) including MMS-IR and Endoscope-IR	2020-02-26
PMN K152204 | OWN Andrea Mitchell [Given Imaging Inc.]	VS3 Iridium (VS3-IR) including MMS-IR and Endoscope-IR	2020-02-26
PMN K152204 | HRX Andrea Mitchell [Given Imaging Inc.]	VS3 Iridium (VS3-IR) including MMS-IR and Endoscope-IR	2020-02-26
PMN K152204 | GWG Andrea Mitchell [Given Imaging Inc.]	VS3 Iridium (VS3-IR) including MMS-IR and Endoscope-IR	2020-02-26
PMN K152204 | GCJ Andrea Mitchell [Given Imaging Inc.]	VS3 Iridium (VS3-IR) including MMS-IR and Endoscope-IR	2020-02-26
PMN K150018 | OWN Andrea Mitchell [Given Imaging Inc.]	VS3 Iridium (VS3-IR-MMS) with MMS-IR Only	2020-02-26
PMN K180171 | PGD Andrea Mitchell [Given Imaging Inc.]	Patency Capsule	2019-09-02
PMN K180171 | NSI Andrea Mitchell [Given Imaging Inc.]	Patency Capsule	2019-09-02
PMN K180171 | NEZ Andrea Mitchell [Given Imaging Inc.]	Patency Capsule	2019-09-02
PMN K994428 | GEI Andrea Mitchell [Medtronic]	Valleylab	2019-04-08
PMN K994428 | GEI Andrea Mitchell [Medtronic]	REM Polyhesive Neonatal Patient Return Electrode	2019-04-08
PMN K170210 | PGD Andrea Mitchell [Given Imaging Inc.]	PillCam software	2017-11-16
PMN K170210 | PGD Andrea Mitchell [Given Imaging Inc.]	PillCam endoscopy system	2017-11-16
PMN K170210 | PGD Andrea Mitchell [Given Imaging Inc.]	PillCam Crohn capsule	2017-11-16
PMN K170210 | NEZ Andrea Mitchell [Given Imaging Inc.]	PillCam software	2017-11-16
PMN K170210 | NEZ Andrea Mitchell [Given Imaging Inc.]	PillCam endoscopy system	2017-11-16
PMN K170210 | NEZ Andrea Mitchell [Given Imaging Inc.]	PillCam Crohn capsule	2017-11-16
PMN K151086 | FFX Andrea Mitchell [Given Imaging Inc.]	ManoView ESO sw	2016-07-19
PMN K151086 | FFX Andrea Mitchell [Given Imaging Inc.]	ManoView AR sw	2016-07-19
PMN K151086 | FFX Andrea Mitchell [Given Imaging Inc.]	ManoShield (disposable sanitary sheaths)	2016-07-19
PMN K151086 | FFX Andrea Mitchell [Given Imaging Inc.]	ManoScan sw	2016-07-19
PMN K151086 | FFX Andrea Mitchell [Given Imaging Inc.]	ManoScan base pressure module ( A120)	2016-07-19
PMN K151086 | FFX Andrea Mitchell [Given Imaging Inc.]	ManoScan System	2016-07-19
PMN K151086 | FFX Andrea Mitchell [Given Imaging Inc.]	ManoScan Impedance module (Z) A200	2016-07-19
PMN K151086 | FFX Andrea Mitchell [Given Imaging Inc.]	ManoScan 3D HRM A300 module	2016-07-19
PMN K151086 | FFX Andrea Mitchell [Given Imaging Inc.]	Disposable Balloons	2016-07-19
PMN K153466 | PGD Andrea Mitchell [Given Imaging Inc.]	RAPID Software	2016-01-18
PMN K153466 | PGD Andrea Mitchell [Given Imaging Inc.]	PillCam COLON 2 Capsule	2016-01-18
PMN K153466 | PGD Andrea Mitchell [Given Imaging Inc.]	Endoscopy System	2016-01-18
PMN K140284 | NSI Andrea Mitchell [Given Imaging Inc.]	RAPID 8	2015-01-05
PMN K140284 | NSI Andrea Mitchell [Given Imaging Inc.]	PillCam UGI Capsule	2015-01-05
PMN K140284 | NSI Andrea Mitchell [Given Imaging Inc.]	DR3	2015-01-05
PMN K140284 | NSI Andrea Mitchell [Given Imaging Inc.]	Accessories	2015-01-05
PMN K140284 | NEZ Andrea Mitchell [Given Imaging Inc.]	RAPID 8	2015-01-05
PMN K140284 | NEZ Andrea Mitchell [Given Imaging Inc.]	PillCam UGI Capsule	2015-01-05
PMN K140284 | NEZ Andrea Mitchell [Given Imaging Inc.]	DR3	2015-01-05
PMN K140284 | NEZ Andrea Mitchell [Given Imaging Inc.]	Accessories	2015-01-05
PMN K123864 | NEZ Andrea Mitchell [Given Imaging Inc.]	SB 3	2013-08-15
PMN K102543 | FFT Andrea Mitchell [Given Imaging Inc.]	Reflux and AccuView software	2013-07-24
PMN K102543 | FFT Andrea Mitchell [Given Imaging Inc.]	Bravo? Reflux Capsule with Delivery Device	2013-07-24
PMN K102543 | FFT Andrea Mitchell [Given Imaging Inc.]	Bravo? CF reflux recorder	2013-07-24
PMN K102543 | FFT Andrea Mitchell [Given Imaging Inc.]	Bravo pH Recorder	2013-07-24
PMN K102543 | FFT Andrea Mitchell [Given Imaging Inc.]	Bravo pH Delivery System Accessories	2013-07-24
PMN K102543 | FFT Andrea Mitchell [Given Imaging Inc.]	Bravo pH Capsule with Delivery Device	2013-07-24
PMN K102543 | FFT Andrea Mitchell [Given Imaging Inc.]	Bravo System	2013-07-24
PMN K092342 | NYV Andrea Mitchell [Given Imaging Inc.]	SmartPill pH.p Capsule	2012-10-31
PMN K092342 | NYV Andrea Mitchell [Given Imaging Inc.]	SmartPill MotiliGI Software	2012-10-31
PMN K092342 | NYV Andrea Mitchell [Given Imaging Inc.]	SmartPill GI Monitoring System, version 2.0	2012-10-31
PMN K092342 | NYV Andrea Mitchell [Given Imaging Inc.]	SmartPill Docking Station	2012-10-31
PMN K092342 | NYV Andrea Mitchell [Given Imaging Inc.]	SmartPill Data Receiver	2012-10-31
PMN K092342 | NYV Andrea Mitchell [Given Imaging Inc.]	SmartPill Capsule Calibration Fluid	2012-10-31
PMN K092342 | NYV Andrea Mitchell [Given Imaging Inc.]	Activation Fixture	2012-10-31
FFT Andrea Mitchell [Given Imaging Inc.]	pHersaflex pH catheters	2012-01-09
FFT Andrea Mitchell [Given Imaging Inc.]	Versaflex pH catheters	2012-01-09
FFT Andrea Mitchell [Given Imaging Inc.]	Versaflex pH Z catheters	2012-01-09
FFT Andrea Mitchell [Given Imaging Inc.]	Reflux software	2012-01-09
FFT Andrea Mitchell [Given Imaging Inc.]	Digitrapper pH Z	2012-01-09
FFT Andrea Mitchell [Given Imaging Inc.]	AccuView pH & pH-Z software	2012-01-09

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020060159654	Yantian,China (Mainland) -> Oakland, California	NAIL GLUE NAIL GLUE	1 PCS
20200501119610	Yantian,China (Mainland) -> Oakland, California	JEANS	1 PCS
2019120778935	Halifax, NS,Canada -> West Palm Beach, Florida	PASTA , GRAINS , FLOUR , RICE , CLOTHING	1 BBL