PMA P050023S105
- Device
- PACEMAKER ICD CRT NON IMPLANTED COMPONENTS
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S105
- Product code
- MRM
- Decision date
- 2017-05-04
- Classification
- Defibrillator, Implantable, Dual-chamber
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- Approval for the Sentus ProMRI OTW QP L/S family of left ventricular pacing leads.
Current openFDA PMA Record#
- Device
- PACEMAKER ICD CRT NON IMPLANTED COMPONENTS
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S105
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2017-05-04
- Decision code
- APPR
- Date received
- 2016-12-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Sentus ProMRI OTW QP L/S family of left ventricular pacing leads.