ADVISA SR MRI
FDA premarket approval P980035/S427 · decided 2015-06-27
Approval details
- PMA number
- P980035
- Supplement
- S427
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADVISA SR MRI
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2015-06-03
- Decision date
- 2015-06-27
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- FOUR (4) MANUFACTURING CHANGES FOR THE ADVISA SR MRI MODEL A3SR01 THAT HAD BEEN PREVIOUSLY APPROVED FOR PREDECESSOR DEVICES TO ALIGN THE ADVISA SR MRIMANUFACTURING PROCESS WITH THE PREDECESSOR DEVICE MANUFACTURING PROCESSES:1) IC SUPPLIER PROCESS FLOW UPDATE TO BICMOS;1) ADDITIONAL LEAK TEST STATION FOR MEDIUM RATE BATTERY; 2) ADDITIONAL WORK STATIONS AT MEDIUM RATE BATTERY SUPPLIER; AND3) FINAL PACK EQUIPMENT IMPLEMENTATION (COQUILPULS LINE) ¿ PHASE II.
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510(k) clearances by this applicant
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|---|---|---|
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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