CAPSURE(R) AND CAPSURE(R) SP SILICONE PACING LEADS
FDA premarket approval P850089/S037 · decided 1997-11-21
Approval details
- PMA number
- P850089
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CAPSURE(R) AND CAPSURE(R) SP SILICONE PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1997-10-10
- Decision date
- 1997-11-21
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a change in connector design for the Model 5023M pacing lead.
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