THINLINE ENDOCARDIAL PACING LEADS
FDA premarket approval P960004 · decided 1996-11-12
Approval details
- PMA number
- P960004
- Trade name
- THINLINE ENDOCARDIAL PACING LEADS
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 1996-01-29
- Decision date
- 1996-11-12
- Days to decision
- 288 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- 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
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