Sprint Quattro Lead
FDA premarket approval P920015/S230 · decided 2019-06-19
Approval details
- PMA number
- P920015
- Supplement
- S230
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Sprint Quattro Lead
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2019-05-20
- Decision date
- 2019-06-19
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Update the proximal sleeve head component, to update the helix shaft assembly fixture and to add visual inspection criteria for the proximal sleeve head of Sprint Quattro leads.
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