Thinline Endocardial Pacing Leads
FDA premarket approval P960004 · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
PMA numberP960004
Approval
- Applicant
- Boston Scientific
- Received
- January 29, 1996
- Decision date
- November 12, 1996 (APPR)
- Supplements
- 103, latest June 3, 2026
- Product code
- NVN – Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
Approval order statement
APPROVAL FOR THE THINLINE(TM) MODELS 430-10 AND 432-04 ENDOCARDIAL PACING LEADS INDICATED FOR CHRONIC PACING AND SENSING OF THE ATRIUM OR VENTRICLE WHEN USED WITH A COMPATIBLE PULSE GENERATOR