SUREFIX TM MODEL 5072 LEAD
FDA premarket approval P930039/S004 · decided 1998-06-03
Approval details
- PMA number
- P930039
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SUREFIX TM MODEL 5072 LEAD
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic, Inc.
- Date received
- 1997-11-17
- Decision date
- 1998-06-03
- Days to decision
- 198 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the SureFix(TM) Model 5072 Steroid-Eluting Screw-In Pacing Lead with a Non-Retractable Helix. The device, as modified, will be marketed under the trade name SureFix(TM) Model 5072 Pacing Lead and is designed to be used with a pulse generator as part of a cardiac pacing system. The lead has application where implantable atrial or ventricular, single chamber or dual chamber pacing systems are indicated.
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