MEDTRONIC CAPSURE SP MODEL 5024M
FDA premarket approval P930039/S013 · decided 2001-12-19
Approval details
- PMA number
- P930039
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Other
- Trade name
- MEDTRONIC CAPSURE SP MODEL 5024M
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2001-11-14
- Decision date
- 2001-12-19
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE FOLLOWING: 1) A CHANGE IN OUTER INSULATION TREATMENT FROM SILACURE TO SILOXANE FOR THE CAPSURE SP MODEL 5024M LEAD; 2) A MATERIAL CHANGE FROM MDX SILICONE TO MED 4719 SILICONE FOR SUREFIX MODEL 5072 INNER AND OUTER INSULATION (OUTER INSULATION WITH SILOXANE TREATMENT); AND 3) ASSOCIATED MINOR LABELING CHANGES.
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510(k) clearances by this applicant
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