MEDTRONIC (R) CAPSURE (R) EPI PACING LEAD MODEL 4695
FDA premarket approval P950024/S004 · decided 2001-08-08
Approval details
- PMA number
- P950024
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC (R) CAPSURE (R) EPI PACING LEAD MODEL 4695
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic, Inc.
- Date received
- 2001-07-17
- Decision date
- 2001-08-08
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE IN THE SUPPLIER OF POLYETHERURETHANE.
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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