PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS
FDA premarket approval P960030 · decided 1998-01-29
Approval details
- PMA number
- P960030
- Trade name
- PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 1996-09-09
- Decision date
- 1998-01-29
- Days to decision
- 507 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the Passive Plus(R) DX Endocardial, Steroid Eluting, Passive-Fixation Pacing Leads, Models 1342T, 1343K, 1346T, and 1345K. This device is indicated for use in combination with a compatible pulse generator to provide permanent pacing and sensing in either the atrium (Models 1342T or 1343K) or ventricle (Models 1345K or 1346T).
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