MEDTRONIC SIGMA AND MEDTRONIC 350 SERIES PULSE GENERATORS
FDA premarket approval P980035/S017 · decided 2001-12-28
Approval details
- PMA number
- P980035
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC SIGMA AND MEDTRONIC 350 SERIES PULSE GENERATORS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2001-11-30
- Decision date
- 2001-12-28
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE IN THE CLEANING PROCESS TO ADD AN ATMOSPHERIC GLOW DISCHARGE PROCESS IN PLACE OF THE HEPTANE WIPE.
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