Cortronik G M B H

FDA Filings

This page includes the latest FDA filings for Cortronik G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3011574793
FEI Number3011574793
NameCORTRONIK GmbH
Owner & OperatorBIOTRONIK AG
Contact AddressAckerstrasse 6
Buelach CH-ZH Zurich CH-8180 CH
Official Correspondent
  • Johannes Bremmers
  • 41-44-864-5500
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressFriedrich-Barnewitz-Str. 4a
Rostock-Warnemuende Mecklenburg-Vorpomme, D-18119 DE
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
CORTRONIK GmbH [BIOTRONIK AG]
Orsiro2019-02-22
CORTRONIK GmbH [BIOTRONIK AG]
Papyrus2018-12-26
CORTRONIK GmbH [BIOTRONIK AG]
Pulsar-182017-03-28
CORTRONIK GmbH [BIOTRONIK AG]
PRO-Kinetic Energy2017-02-22
CORTRONIK GmbH [BIOTRONIK AG]
Astron2015-12-22

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