Gemini Theta Model 415A Cardiac Pacer
by Telectronics Pacing Systems, Inc.
PMA P830007
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP830007 | Date12 Feb 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Gemini(R) Theta Model 415A Cardiac Pacer
- Generic Name
- Implantable pulse generator, pacemaker (non-CRT)
- PMA Number
- FDA Product Code
- LWP
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
- PMA Supplement
- S015
Overview
AI-generated summary, 18 Sep 2026
The Gemini Theta Model 415A Cardiac Pacer is an Implantable Pulse Generator, Pacemaker (Non-CRT). This device is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when the natural pacemaker fails to maintain an adequate rate or rhythm, ensuring proper cardiac function in patients with bradycardia or conduction disorders.
This pacemaker is intended for implantable use and is classified as a Class III medical device under FDA regulations. Authorized under FDA_PMA (P830007), it is supplied sterile and intended for single-patient use. The device adheres to MRI safety standards as classified under LWP product code, though specific MRI compatibility details must be confirmed per manufacturer guidelines. Storage and handling follow standard sterile implantable device protocols.
Other devices from Telectronics Pacing Systems, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the purpose of the Gemini Theta Model 415A Cardiac Pacer?
The Gemini Theta Model 415A Cardiac Pacer is an implantable pulse generator designed to regulate heart rhythm by delivering electrical impulses when the natural pacemaker fails to maintain adequate rate or rhythm, treating bradycardia or conduction disorders.
Is the Gemini Theta Model 415A Cardiac Pacer supplied sterile?
Yes, the device is supplied sterile and is intended for single-patient use, following standard sterile implantable device protocols for storage and handling.
What is the regulatory classification of the Gemini Theta Model 415A Cardiac Pacer?
The device is classified as a Class III medical device under FDA regulations and is authorized under FDA_PMA (P830007), with product code LWP.
Is the Gemini Theta Model 415A Cardiac Pacer MRI compatible?
The device adheres to MRI safety standards as classified under LWP product code, though specific MRI compatibility details must be confirmed per manufacturer guidelines.