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Biotronik, Inc. FDA Approvals

0 new drug approvals and 11 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
BIOMONITOR IV (471155)510(k)May 1, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	May 1, 2026
Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter510(k)Apr 4, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Apr 4, 2025
Pantera Pro; Pantera LEO510(k)Oct 25, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Oct 25, 2024
Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)510(k)Sep 12, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 12, 2024
Oscar Peripheral Multifunctional Catheter system510(k)Jul 11, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Jul 11, 2024
BIOMONITOR IV510(k)May 19, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 19, 2023
Passeo-35 Xeo Peripheral Dilatation Catheter510(k)Feb 16, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 16, 2023
BIOMONITOR IIIm, BIOMONITOR III510(k)Jul 27, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Jul 27, 2022
Selectra Lead Implantation System510(k)Jul 19, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Jul 19, 2022
Oscar Peripheral Multifunctional Catheter system510(k)Jul 6, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 6, 2022
MultiCath, AcQRate Dx Fixed Curve Catheter510(k)Sep 2, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 2, 2021

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