CAPSURE SENSE LEAD MODELS
FDA premarket approval P830061/S034 · decided 2002-07-23
Approval details
- PMA number
- P830061
- Supplement
- S034
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CAPSURE SENSE LEAD MODELS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2002-03-01
- Decision date
- 2002-07-23
- Days to decision
- 144 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR PACING LEADS THAT INCORPORATE A NEW SURFACE COATING, A NEW ELECTRODE GEOMETRY, A NEW COMBINATION OF PREVIOUSLY USED STEROIDS, AND A NEW TAPERED STYLET. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES CAPSURE SENSE LEAD MODELS 4074/4574/4073 AND THE VITATRON CRYSTALLINE LEAD MODELS ICM09B, ICM09JB, AND ICM09. THESE DEVICES ARE INDICATED FOR PACING OR SENSING IN THE ATRIUM OR VENTRICLE. THE LEADS HAVE APPLICATION WHERE IMPLANTABLE ATRIAL OR VENTRICULAR SINGLE-CHAMBER O
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