CAPSURE SP NOVUS
FDA premarket approval P850089/S040 · decided 1998-10-29
Approval details
- PMA number
- P850089
- Supplement
- S040
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CAPSURE SP NOVUS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1998-10-01
- Decision date
- 1998-10-29
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for distribution under a new trade name. The devices will be marketed under the trade name Vitatron(R) Excellence SS+ Models IML 49B and IML 49JB and indicated for use with pulse generators as part of a caridac pacing system to provide chronic pacing and sensing of the ventricle.
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