PMA P820076S018
- Device
- BIOTRONIK GEMNOS 04 AND GEMNOS TC O4
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S018
- Product code
- LWP
- Decision date
- 1996-11-21
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- USE OF SELF-SEALING HEADER AND SPRING CONTACTOR, WHICH REPLACES THE CURRENT HEADER DESIGN UTILIZING SEPARABLE SETSCREWS AND SEALING CAPS
Current openFDA PMA Record#
- Device
- BIOTRONIK GEMNOS 04 AND GEMNOS TC O4
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S018
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1996-11-21
- Decision code
- APPR
- Date received
- 1995-02-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- USE OF SELF-SEALING HEADER AND SPRING CONTACTOR, WHICH REPLACES THE CURRENT HEADER DESIGN UTILIZING SEPARABLE SETSCREWS AND SEALING CAPS