Pinnacle SR 8701 Unipolar & 8702 Bipolar

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K870142 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pinnacle Multi-Programmable Pacing Sys

  Class III

  FDA 510(k) K853771 Active Cleared 15 Jul 1986

• Durapulse P101 Coated Pulse Generator

  Class III

  FDA 510(k) K853425 Active Cleared 19 Aug 1985

• Are these pacemakers designed for use in patients who require both unipolar and bipolar pacing options, and how does that affect their clinical application?

  The Pinnacle SR models (8701 Unipolar and 8702 Bipolar) are distinct devices tailored for specific pacing configurations. The 8701 Unipolar delivers electrical impulses through a single electrode, while the 8702 Bipolar uses two electrodes, which can reduce muscle stimulation and improve pacing thresholds. Clinicians may choose between them based on patient anatomy, lead placement, or pacing efficiency requirements. Both are intended for single-patient use and implanted surgically in the chest region to regulate cardiac rhythm.

• How are these devices supplied, and what precautions should be taken during handling to maintain sterility?

  The Pinnacle SR 8701 and 8702 pulse-generators are supplied sterile and intended for single-patient use only. They must be handled using aseptic techniques to prevent contamination before implantation. The sterile packaging should remain intact until the device is ready for surgical use, and any exposed components must be discarded to avoid compromising sterility. These devices are not designed for reuse or reprocessing.

• What storage conditions are recommended for these pacemakers before implantation, and are there any special handling instructions?

  While specific storage conditions aren’t detailed in the provided data, implantable pulse-generators like the Pinnacle SR typically require protection from extreme temperatures, moisture, and physical damage. They should be stored in their original, sealed packaging in a clean, dry environment until use. Avoid exposure to direct sunlight or magnetic fields, though MRI compatibility is not mentioned, so caution is advised if MRI exposure is anticipated. Always follow manufacturer guidelines if additional storage instructions are provided.

• Are there any differences in the regulatory pathway or approval status between the unipolar and bipolar models, and how does that impact their availability?

  Both the 8701 Unipolar and 8702 Bipolar models are authorized under the same FDA 510(k) clearance (K870142) and fall under regulation 870.3610, confirming they meet cardiovascular device standards. The regulatory pathway is identical for both, meaning they share the same compliance requirements and approval status. Availability depends on the manufacturer’s distribution channels, but neither model requires separate clearance due to their classification as substantially equivalent devices under the same submission.