PMA P980023S088
- Device
- Implantable Cardioverter Defibrillatory (Non-CRT) and Defibrillatort, Implantable, Dual-Chamber
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S088
- Product code
- LWS
- Decision date
- 2018-12-13
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Modifications to the anode pressing fixture used during production of lithium anodes for batteries.
Current openFDA PMA Record#
- Device
- Implantable Cardioverter Defibrillatory (Non-CRT) and Defibrillatort, Implantable, Dual-Chamber
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S088
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-12-13
- Decision code
- OK30
- Date received
- 2018-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the anode pressing fixture used during production of lithium anodes for batteries.