Pacemaker 147 Vvi-the Optinia
510(k) K840701
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK840701 | Date2 May 1984 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXY
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3610
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Pacemaker 147 VVI Optinia is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle. It operates in a VVI (Ventricular-Inhibited, Ventricular-Triggered) mode, ensuring synchronized pacing to maintain proper cardiac function in patients with bradycardia or other conduction disorders.
This device is intended for implantable use and requires surgical placement beneath the skin, typically in the chest area. Supplied sterile and intended for single-use implantation, it is regulated under FDA 510(k) clearance (K840701) and falls under the Cardiovascular advisory committee classification. Compliance with 21 CFR 870.3610 ensures adherence to safety and performance standards for implantable cardiac devices. No additional sterilization or reprocessing is required post-implantation.