Sweet Tip(R) RX Steroid Eluting Lead

FDA premarket approval P960006 · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

PMA numberP960006

Approval

Applicant
Boston Scientific
Received
March 4, 1996
Decision date
October 2, 1998 (APPR)
Supplements
52, latest May 15, 2026
Product code
NVN – Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Official FDA PMA record

Approval order statement

Approval for the SWEET TIP(R) Rx Models 4143, 4144, 4145, 4243, 4244, and 4245 steroid-eluting, positive-fixation, porous tip, pacing leads. These devices are indicated for chronic pacing and sensing of the atrium and/or ventricle when used with a compatible pulse generator.