Tunneling Tool
FDA premarket approval P920015/S296 · decided 2024-12-18
Approval details
- PMA number
- P920015
- Supplement
- S296
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Tunneling Tool
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2024-12-12
- Decision date
- 2024-12-18
- Days to decision
- 6 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- the update to the cleaning process for the rod and stopper for the 6996T tunneling tool
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510(k) clearances by this applicant
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