Sprint Quattro Lead
FDA premarket approval P920015/S180 · decided 2016-06-17
Approval details
- PMA number
- P920015
- Supplement
- S180
- 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
- 2016-05-27
- Decision date
- 2016-06-17
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Change to the adhesive mixture process used during lead backfill.
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