HV Splitter/Adaptor Kit, Sprint Quattro Lead.
FDA premarket approval P920015/S219 · decided 2018-11-09
Approval details
- PMA number
- P920015
- Supplement
- S219
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HV Splitter/Adaptor Kit, Sprint Quattro Lead.
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2018-10-11
- Decision date
- 2018-11-09
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Use of new equipment to perform the dimensional inspections, automation of select adhesive inspections and move both the dimensional and select adhesive inspections to occur in parallel with the electrical test.
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