PMA P830007S019
- Device
- GEMINI(R) THETA MODEL 415A CARDIAC PACER
- Applicant
- Telectronics Pacing Systems, Inc.
- PMA number
- P830007
- Supplement
- S019
- Product code
- LWP
- Decision date
- 1987-01-30
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
Current openFDA PMA Record#
- Device
- GEMINI(R) THETA MODEL 415A CARDIAC PACER
- Applicant
- Telectronics Pacing Systems, Inc.
- PMA number
- P830007
- Supplement
- S019
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 1987-01-30
- Decision code
- APPR
- Date received
- 1986-12-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename