Biotronik Ag

FDA Filings

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

FDA Registration(s)

• Registration Number: 8043892
• FEI Number: 3002808050
• Name: Jon Brumbaugh
• Owner & Operator: BIOTRONIK AG
• Contact Address: Ackerstrasse 6 ; Buelach CH-ZH Zurich CH-8180 CH
• Official Correspondent:
  • Johannes Bremmers
  • 41-44-864-5500
• US Agent:
  • Jon Brumbaugh
  • BIOTRONIK, Inc.
  • 888 3450374
  • 503 6359936
  • jon.brumbaugh@biotronik.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 6024 Jean Road ; Lake Oswego, OR 97035 US
• Establishment Type:
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3011574793
• FEI Number: 3011574793
• Name: CORTRONIK GmbH
• Owner & Operator: BIOTRONIK AG
• Contact Address: Ackerstrasse 6 ; Buelach CH-ZH Zurich CH-8180 CH
• Official Correspondent:
  • Johannes Bremmers
  • 41-44-864-5500
• US Agent:
  • Jon Brumbaugh
  • BIOTRONIK, INC.
  • 503 4518310
  • 503 4518519
  • jon.brumbaugh@biotronik.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Friedrich-Barnewitz-Str. 4a ; Rostock-Warnemuende Mecklenburg-Vorpomme, D-18119 DE
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 07640130452503 Biotronik AG	Passeo-35 Xeo 428879	2023-03-08
GUDID 07640130452497 Biotronik AG	Passeo-35 Xeo 428878	2023-03-08
GUDID 07640130452480 Biotronik AG	Passeo-35 Xeo 428877	2023-03-08
GUDID 07640130452473 Biotronik AG	Passeo-35 Xeo 428876	2023-03-08
GUDID 07640130452466 Biotronik AG	Passeo-35 Xeo 428875	2023-03-08
GUDID 07640130452459 Biotronik AG	Passeo-35 Xeo 428874	2023-03-08
GUDID 07640130452442 Biotronik AG	Passeo-35 Xeo 428873	2023-03-08
GUDID 07640130452435 Biotronik AG	Passeo-35 Xeo 428872	2023-03-08
GUDID 07640130452428 Biotronik AG	Passeo-35 Xeo 428871	2023-03-08
GUDID 07640130452411 Biotronik AG	Passeo-35 Xeo 428870	2023-03-08
GUDID 07640130452404 Biotronik AG	Passeo-35 Xeo 428869	2023-03-08
GUDID 07640130452398 Biotronik AG	Passeo-35 Xeo 428868	2023-03-08
GUDID 07640130452381 Biotronik AG	Passeo-35 Xeo 428867	2023-03-08
GUDID 07640130452374 Biotronik AG	Passeo-35 Xeo 428866	2023-03-08
GUDID 07640130452367 Biotronik AG	Passeo-35 Xeo 428865	2023-03-08
GUDID 07640130452350 Biotronik AG	Passeo-35 Xeo 428864	2023-03-08
GUDID 07640130452343 Biotronik AG	Passeo-35 Xeo 428863	2023-03-08
GUDID 07640130452336 Biotronik AG	Passeo-35 Xeo 428862	2023-03-08
GUDID 07640130452329 Biotronik AG	Passeo-35 Xeo 428861	2023-03-08
GUDID 07640130452312 Biotronik AG	Passeo-35 Xeo 428860	2023-03-08
GUDID 07640130452299 Biotronik AG	Passeo-35 Xeo 428858	2023-03-08
GUDID 07640130452282 Biotronik AG	Passeo-35 Xeo 428857	2023-03-08
GUDID 07640130452275 Biotronik AG	Passeo-35 Xeo 428856	2023-03-08
GUDID 07640130452268 Biotronik AG	Passeo-35 Xeo 428855	2023-03-08
GUDID 07640130452251 Biotronik AG	Passeo-35 Xeo 428854	2023-03-08
GUDID 07640130452244 Biotronik AG	Passeo-35 Xeo 428853	2023-03-08
GUDID 07640130452237 Biotronik AG	Passeo-35 Xeo 428852	2023-03-08
GUDID 07640130452220 Biotronik AG	Passeo-35 Xeo 428851	2023-03-08
GUDID 07640130452213 Biotronik AG	Passeo-35 Xeo 428850	2023-03-08
GUDID 07640130452206 Biotronik AG	Passeo-35 Xeo 428849	2023-03-08
GUDID 07640130452190 Biotronik AG	Passeo-35 Xeo 428848	2023-03-08
GUDID 07640130452183 Biotronik AG	Passeo-35 Xeo 428847	2023-03-08
GUDID 07640130452176 Biotronik AG	Passeo-35 Xeo 428846	2023-03-08
GUDID 07640130452169 Biotronik AG	Passeo-35 Xeo 428845	2023-03-08
GUDID 07640130452152 Biotronik AG	Passeo-35 Xeo 428844	2023-03-08
GUDID 07640130452145 Biotronik AG	Passeo-35 Xeo 428843	2023-03-08
GUDID 07640130452138 Biotronik AG	Passeo-35 Xeo 428842	2023-03-08
GUDID 07640130452121 Biotronik AG	Passeo-35 Xeo 428841	2023-03-08
GUDID 07640130452114 Biotronik AG	Passeo-35 Xeo 428840	2023-03-08
GUDID 07640130452107 Biotronik AG	Passeo-35 Xeo 428839	2023-03-08
GUDID 07640130452091 Biotronik AG	Passeo-35 Xeo 428838	2023-03-08
GUDID 07640130452084 Biotronik AG	Passeo-35 Xeo 428837	2023-03-08
GUDID 07640130452077 Biotronik AG	Passeo-35 Xeo 428836	2023-03-08
GUDID 07640130452060 Biotronik AG	Passeo-35 Xeo 428835	2023-03-08
GUDID 07640130452053 Biotronik AG	Passeo-35 Xeo 428834	2023-03-08
GUDID 07640130452046 Biotronik AG	Passeo-35 Xeo 428833	2023-03-08
GUDID 07640130452039 Biotronik AG	Passeo-35 Xeo 428832	2023-03-08
GUDID 07640130452022 Biotronik AG	Passeo-35 Xeo 428831	2023-03-08
GUDID 07640130452015 Biotronik AG	Passeo-35 Xeo 428830	2023-03-08
GUDID 07640130452008 Biotronik AG	Passeo-35 Xeo 428829	2023-03-08
GUDID 07640130451995 Biotronik AG	Passeo-35 Xeo 428828	2023-03-08
GUDID 07640130451988 Biotronik AG	Passeo-35 Xeo 428827	2023-03-08
GUDID 07640130451971 Biotronik AG	Passeo-35 Xeo 428826	2023-03-08
GUDID 07640130451964 Biotronik AG	Passeo-35 Xeo 428825	2023-03-08
GUDID 07640130451957 Biotronik AG	Passeo-35 Xeo 428824	2023-03-08
GUDID 07640130451940 Biotronik AG	Passeo-35 Xeo 428823	2023-03-08
GUDID 07640130451933 Biotronik AG	Passeo-35 Xeo 428822	2023-03-08
GUDID 07640130451926 Biotronik AG	Passeo-35 Xeo 428821	2023-03-08
GUDID 07640130451919 Biotronik AG	Passeo-35 Xeo 428820	2023-03-08
GUDID 07640130451902 Biotronik AG	Passeo-35 Xeo 428819	2023-03-08
GUDID 07640130451896 Biotronik AG	Passeo-35 Xeo 428818	2023-03-08
GUDID 07640130451889 Biotronik AG	Passeo-35 Xeo 428817	2023-03-08
GUDID 07640130451872 Biotronik AG	Passeo-35 Xeo 428816	2023-03-08
GUDID 07640130451865 Biotronik AG	Passeo-35 Xeo 428815	2023-03-08
GUDID 07640130451858 Biotronik AG	Passeo-35 Xeo 428814	2023-03-08
GUDID 07640130451841 Biotronik AG	Passeo-35 Xeo 428813	2023-03-08
GUDID 07640130451834 Biotronik AG	Passeo-35 Xeo 428812	2023-03-08
GUDID 07640130451827 Biotronik AG	Passeo-35 Xeo 428811	2023-03-08
GUDID 07640130451810 Biotronik AG	Passeo-35 Xeo 428810	2023-03-08
GUDID 07640130451803 Biotronik AG	Passeo-35 Xeo 428809	2023-03-08
GUDID 07640130451797 Biotronik AG	Passeo-35 Xeo 428808	2023-03-08
GUDID 07640130451780 Biotronik AG	Passeo-35 Xeo 428807	2023-03-08
GUDID 07640130451773 Biotronik AG	Passeo-35 Xeo 428806	2023-03-08
GUDID 07640130451766 Biotronik AG	Passeo-35 Xeo 428805	2023-03-08
GUDID 07640130451759 Biotronik AG	Passeo-35 Xeo 428804	2023-03-08
GUDID 07640130451742 Biotronik AG	Passeo-35 Xeo 428803	2023-03-08
GUDID 07640130451735 Biotronik AG	Passeo-35 Xeo 428802	2023-03-08
GUDID 07640130451728 Biotronik AG	Passeo-35 Xeo 428801	2023-03-08
GUDID 07640130451711 Biotronik AG	Passeo-35 Xeo 428800	2023-03-08
GUDID 07640130451704 Biotronik AG	Passeo-35 Xeo 428799	2023-03-08
GUDID 07640130451698 Biotronik AG	Passeo-35 Xeo 428798	2023-03-08
GUDID 07640130451681 Biotronik AG	Passeo-35 Xeo 428797	2023-03-08
GUDID 07640130451674 Biotronik AG	Passeo-35 Xeo 428796	2023-03-08
GUDID 07640130451667 Biotronik AG	Passeo-35 Xeo 428795	2023-03-08
GUDID 07640130451650 Biotronik AG	Passeo-35 Xeo 428794	2023-03-08
GUDID 07640130451643 Biotronik AG	Passeo-35 Xeo 428793	2023-03-08
GUDID 07640130451636 Biotronik AG	Passeo-35 Xeo 428792	2023-03-08
GUDID 07640130451629 Biotronik AG	Passeo-35 Xeo 428791	2023-03-08
GUDID 07640130451612 Biotronik AG	Passeo-35 Xeo 428790	2023-03-08
GUDID 07640130451605 Biotronik AG	Passeo-35 Xeo 428789	2023-03-08
GUDID 07640130451599 Biotronik AG	Passeo-35 Xeo 428788	2023-03-08
GUDID 07640130451582 Biotronik AG	Passeo-35 Xeo 428787	2023-03-08
GUDID 07640130451575 Biotronik AG	Passeo-35 Xeo 428786	2023-03-08
GUDID 07640130451551 Biotronik AG	Passeo-35 Xeo 428784	2023-03-08
GUDID 07640130451544 Biotronik AG	Passeo-35 Xeo 428783	2023-03-08
GUDID 07640130451537 Biotronik AG	Passeo-35 Xeo 428782	2023-03-08
GUDID 07640130451520 Biotronik AG	Passeo-35 Xeo 428781	2023-03-08
GUDID 07640130451513 Biotronik AG	Passeo-35 Xeo 428780	2023-03-08
GUDID 07640130451506 Biotronik AG	Passeo-35 Xeo 428779	2023-03-08
GUDID 07640130451490 Biotronik AG	Passeo-35 Xeo 428778	2023-03-08
PMN P170030 | NIQ Jon Brumbaugh [BIOTRONIK AG]	Orsiro	2019-02-22
PMN P170030 | NIQ CORTRONIK GmbH [BIOTRONIK AG]	Orsiro	2019-02-22
PMN H170004 | NIV Jon Brumbaugh [BIOTRONIK AG]	Papyrus	2018-12-26
PMN H170004 | NIV CORTRONIK GmbH [BIOTRONIK AG]	Papyrus	2018-12-26
PMN K130146 | NDN Jon Brumbaugh [BIOTRONIK AG]	SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM	2017-05-17
PMN K130146 | HRX Jon Brumbaugh [BIOTRONIK AG]	SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM	2017-05-17
PMN P160025 | NIP Jon Brumbaugh [BIOTRONIK AG]	Pulsar-18	2017-03-28
PMN P160025 | NIP CORTRONIK GmbH [BIOTRONIK AG]	Pulsar-18	2017-03-28
PMN P160003 | MAF Jon Brumbaugh [BIOTRONIK AG]	PRO-Kinetic Energy	2017-02-22
PMN P160003 | MAF CORTRONIK GmbH [BIOTRONIK AG]	PRO-Kinetic Energy	2017-02-22
PMN K163660 | LOX Jon Brumbaugh [BIOTRONIK AG]	Pantera LEO	2017-01-27
PMN K160985 | LOX Jon Brumbaugh [BIOTRONIK AG]	Pantera Pro	2016-10-12
PMN K153197 | DYB Jon Brumbaugh [BIOTRONIK AG]	Fortress 5/6F	2016-01-21
PMN K153197 | DRE Jon Brumbaugh [BIOTRONIK AG]	Fortress 5/6F	2016-01-21
PMN P140030 | NIO Jon Brumbaugh [BIOTRONIK AG]	Astron	2015-12-22
PMN P140030 | NIO CORTRONIK GmbH [BIOTRONIK AG]	Astron	2015-12-22
PMN K152240 | LIT Jon Brumbaugh [BIOTRONIK AG]	Passeo-14	2015-12-15
PMN K142379 | LIT Jon Brumbaugh [BIOTRONIK AG]	Passeo-35	2014-12-05
PMN K090193 | DQX Jon Brumbaugh [BIOTRONIK AG]	Galeo	2014-06-03
PMN K113468 | LIT Jon Brumbaugh [BIOTRONIK AG]	Passeo-35 HP	2013-09-06
PMN K113468 | DQY Jon Brumbaugh [BIOTRONIK AG]	Passeo-35 HP	2013-09-06
PMN K102211 | DQX Jon Brumbaugh [BIOTRONIK AG]	Cruiser-18	2011-07-22
PMN K100799 | DYB Jon Brumbaugh [BIOTRONIK AG]	Fortress	2011-07-22
PMN K082933 | DQY Jon Brumbaugh [BIOTRONIK AG]	Passeo-35	2011-07-22
PMN K072765 | LIT Jon Brumbaugh [BIOTRONIK AG]	Passeo-18	2008-02-14
PMN K052757 BIOTRONIK AG	PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER	2005-10-28

Similar & Related FDA Registered Companies

• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS243 Date Received11/23/2022 Decision Date12/16/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS117 Date Received11/23/2022 Decision Date12/16/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
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• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS137 Date Received06/17/2022 Decision Date06/21/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS167 Date Received06/17/2022 Decision Date06/21/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP160025 Supplement NumberS014 Date Received04/20/2022 Decision Date05/20/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS112 Date Received02/17/2022 Decision Date03/15/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS235 Date Received02/17/2022 Decision Date03/15/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS135 Date Received02/01/2022 Decision Date02/28/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Biotronik, Inc6024 Jean Roadlake Oswego, OR 97035 PMA NumberP170030 Supplement NumberS021 Date Received01/31/2022 Decision Date02/23/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018010151284	Vancouver, BC ,Canada -> Oakland, California	EXCESS PACKAGING MATERIAL EQUIPMENT 8456.11, 9011.10,5402.49, 8207.30,3824.99, 48	15 PKG