PASSIVE PLUS DX ENDOCARDIAL, STEROID ELUTING, PASSIVE FIXATION PACING LEADS
FDA premarket approval P960030/S005 · decided 1999-08-26
Approval details
- PMA number
- P960030
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PASSIVE PLUS DX ENDOCARDIAL, STEROID ELUTING, PASSIVE FIXATION PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- ABBOTT MEDICAL
- Date received
- 1999-04-01
- Decision date
- 1999-08-26
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the Model 1336T Passive Plus(R) DX Endocardial, Steroid Eluting, Passive Fixation pacing lead. This device is indicated for permanent pacing and sensing of the ventricle when used with a compatible pulse generator.
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