MEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB
FDA premarket approval P830061/S027 · decided 1998-08-27
Approval details
- PMA number
- P830061
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1998-03-02
- Decision date
- 1998-08-27
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for new pacing leads models. The devices, as modified, will be marketed under the trade names CapSure(R) SP Novus Models 4092 and 4592 and Vitatron Excellence PS+ Models IMK49B and IMK49JB and are indicated for permanent pacing and sensing of the strium or ventricle.
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