Atlas FDA

ACROS DR/SR/SLR/D/S,AXIOS DR/SR/SLR/D/S,BA03 DDDR,CYLOS DR/DR-T/VR,DROMOS DR/SR/SL,KAIROS DR/SR/SL/D/S,PHILOS DR/DR-T/S

FDA premarket approval P950037/S160 · decided 2016-04-13

Approval details

PMA number
P950037
Supplement
S160
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
ACROS DR/SR/SLR/D/S,AXIOS DR/SR/SLR/D/S,BA03 DDDR,CYLOS DR/DR-T/VR,DROMOS DR/SR/SL,KAIROS DR/SR/SL/D/S,PHILOS DR/DR-T/S
Generic name
Pulse generator, permanent, implantable
Applicant
Biotronik, Inc.
Date received
2015-12-16
Decision date
2016-04-13
Days to decision
119 days
Decision code
APPR
Product code
NVZ
Advisory committee
Cardiovascular
Expedited review
No
Location
Lake Oswego, OR
Statement
Approval for the PSW 1506.U Programmer Software.

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510(k) clearances by this applicant

RecordFirmDate
BIOMONITOR IV (471155) (K261074)Biotronik, Inc.2026-05-01
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Pantera Pro; Pantera LEO (K242969)Biotronik, Inc.2024-10-25
Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) (K240787)Biotronik, Inc.2024-09-12
Oscar Peripheral Multifunctional Catheter system (K241711)Biotronik, Inc.2024-07-11
BIOMONITOR IV (K230375)Biotronik, Inc.2023-05-19
Passeo-35 Xeo Peripheral Dilatation Catheter (K222065)Biotronik, Inc.2023-02-16
BIOMONITOR IIIm, BIOMONITOR III (K221856)Biotronik, Inc.2022-07-27