Gemini(R) Theta Model 415A Cardiac Pacer
FDA premarket approval P830007 · Implantable pulse generator, pacemaker (non-CRT)
PMA numberP830007
Approval
- Applicant
- Telectronics Pacing Systems, Inc.
- Received
- February 7, 1983
- Decision date
- November 10, 1983 (APPR)
- Supplements
- 30, latest May 9, 1990
- Product code
- LWP – Implantable Pulse Generator, Pacemaker (Non-Crt)