Thinline II Endocardial Pacing Leads
PMA P960004
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP960004 | Date12 Nov 1996 | 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- Withdrawn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
- Fineline II
- Trade name
- Thinline Endocardial Pacing Leads
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- PMA number
- FDA product code
- NVN
- Device class
- Class III
- Advisory committee
- Cardiovascular
- FDA decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Thinline II Endocardial Pacing Leads are drug-eluting permanent electrodes designed for chronic pacing and sensing of the right ventricle (RV) or right atrium (RA). Classified as Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes, these leads are intended for implantation with a compatible pulse generator to support cardiac rhythm management.
These leads are supplied sterile and intended for single-use. They are regulated under FDA Premarket Approval (PMA) with the approval number P960004, and fall under product code NVN. The device is manufactured by Boston Scientific and is intended for use in clinical settings requiring endocardial pacing, adhering to strict medical device standards for cardiovascular applications.
Other devices from Boston Scientific
Questions
AI-generated answers, 18 Sep 2026
What are the primary uses for the Thinline II Endocardial Pacing Leads in clinical practice?
The Thinline II Endocardial Pacing Leads are designed for chronic pacing and sensing of the right ventricle (RV) or right atrium (RA) in patients requiring cardiac rhythm management. They are intended to be implanted with a compatible pulse generator to support long-term pacing needs in clinical settings.
Are the Thinline II Endocardial Pacing Leads reusable or intended for single-use?
The Thinline II Endocardial Pacing Leads are explicitly supplied sterile and intended for **single-use only**. This ensures patient safety and reduces the risk of infection or contamination from repeated use.
How is the regulatory approval status of this device determined?
The Thinline II Endocardial Pacing Leads hold **FDA Premarket Approval (PMA)** under approval number **P960004**, indicating they underwent rigorous review by the FDA before commercialization. This classification applies to Class III devices, which require PMA due to their higher risk profile.
What models of Thinline II Endocardial Pacing Leads are available, and where are they manufactured?
The approved models include **430-10 (for atrial pacing)** and **432-04 (for ventricular pacing)**, as indicated in the advisory committee description. These leads are manufactured by **Boston Scientific** at their facility in **St. Paul, Minnesota (MN)**.
How should the Thinline II Endocardial Pacing Leads be stored to maintain their integrity?
While specific storage instructions aren’t detailed in the provided data, sterile medical devices like these typically require protection from moisture, extreme temperatures, and physical damage. The packaging should remain unopened until immediate use, and any post-manufacture storage should follow the manufacturer’s guidelines to preserve sterility and functionality.