PMA P950037S148
- Device
- ACTROS/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/D
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S148
- Product code
- OSR
- Decision date
- 2015-04-09
- Classification
- Pacemaker/icd/crt Non-implanted Components
- Generic name
- Pacemaker/icd/crt non-implanted components
- Approval order statement
- APPROVAL FOR UPDATES TO YOUR ICS 3000/RENAMIC PROGRAMMERSOFTWARE (1501.U).
Current openFDA PMA Record#
- Device
- ACTROS/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/D
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S148
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- Decision date
- 2015-04-09
- Decision code
- APPR
- Date received
- 2015-02-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR UPDATES TO YOUR ICS 3000/RENAMIC PROGRAMMERSOFTWARE (1501.U).