PMA P000009S034
- Device
- BELOS VR-T, DR-T & A+-T; LEXOS DR-T & VR-T; XELOS DR-T; LUMOS DR-T & VR-T
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S034
- Product code
- MRM
- Decision date
- 2009-03-23
- Classification
- Defibrillator, Implantable, Dual-chamber
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- APPROVAL FOR AND UPDATE TO THE BIOTRONIK HOME MONITORING SERVICE CENTER TO VERSION 3.2.
Current openFDA PMA Record#
- Device
- BELOS VR-T, DR-T & A+-T; LEXOS DR-T & VR-T; XELOS DR-T; LUMOS DR-T & VR-T
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S034
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2009-03-23
- Decision code
- APPR
- Date received
- 2009-02-13
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AND UPDATE TO THE BIOTRONIK HOME MONITORING SERVICE CENTER TO VERSION 3.2.