PMA P050023S051
- Device
- LUMAX ICDS AND CRT-DS
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S051
- Product code
- MRM
- Decision date
- 2012-03-05
- Classification
- Defibrillator, Implantable, Dual-chamber
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- NEW LASER WELD PROCESS TO WELD CONNECTION BANDS TO NICKEL PADS.
Current openFDA PMA Record#
- Device
- LUMAX ICDS AND CRT-DS
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S051
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2012-03-05
- Decision code
- OK30
- Date received
- 2012-02-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- NEW LASER WELD PROCESS TO WELD CONNECTION BANDS TO NICKEL PADS.