CAPSURE FIX MODELS 4067,4068, 4568,5068,5568 PACING LEADS
FDA premarket approval P930039/S005 · decided 1998-09-01
Approval details
- PMA number
- P930039
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CAPSURE FIX MODELS 4067,4068, 4568,5068,5568 PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic, Inc.
- Date received
- 1998-03-02
- Decision date
- 1998-09-01
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for modifications to the CapSureFix(R) pacing lead family.
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510(k) clearances by this applicant
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|---|---|---|
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