CAPSURE Z NOVUS/CAPSURE SP NOVUS TRANSVENOUS TINED PACING LEADS
FDA premarket approval P850089/S038 · decided 1998-06-01
Approval details
- PMA number
- P850089
- Supplement
- S038
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CAPSURE Z NOVUS/CAPSURE SP NOVUS TRANSVENOUS TINED PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1997-11-03
- Decision date
- 1998-06-01
- Days to decision
- 210 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the addition of four transvenous leads to the CapSure(R) product line. The device, will be marketed under the trade names CapSure(R) Z Novus Models 5054 and 5554 and CapSure(R) SP Novus Models 5092 and 5592 and are indicated for pacing and sensing in the atrium or ventricle where implantable atrial or ventricular, single-chamber or dual-chamber pacing systems are indicated.
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