HV SPLITTER/ADAPTOR KIT; SPRINT QUATTRO LEAD; SUBCUTANEOUS LEAD ; TRANSVENE CS/SVC LEAD
FDA premarket approval P920015/S190 · decided 2016-12-19
Approval details
- PMA number
- P920015
- Supplement
- S190
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HV SPLITTER/ADAPTOR KIT; SPRINT QUATTRO LEAD; SUBCUTANEOUS LEAD ; TRANSVENE CS/SVC LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2016-11-28
- Decision date
- 2016-12-19
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Updates to the inspection procedure for Titanium Dioxide containing pigment paste to allow usage of a new test method.
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510(k) clearances by this applicant
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|---|---|---|
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| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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