CAPSURE Z MODELS 5034/5534/5033 PACING LEADS
FDA premarket approval P850089/S033 · decided 1995-12-21
Approval details
- PMA number
- P850089
- Supplement
- S033
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CAPSURE Z MODELS 5034/5534/5033 PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1995-04-06
- Decision date
- 1995-12-21
- Days to decision
- 259 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MODELS 5034, 5534, 5033 PACING LEADS - THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES CAPSURE Z MODEL 5-34, 5534, AND 5033 PACING LEADSAND HAVE APPLICATIONS WHERE PERMANENT VENTRICULAR, ATRIAL, OR DUAL CHAMBERED PACING SYSTEMS ARE INDICATED. THE LEADS ARE USED TO PROVIDE CHANNELED, ELECTRICALLY CONDUCTIVE PATHWASY BETWEEN THE PULSE GENERATOR AND THE HEART
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