DEMA IPG/C & T SERIES IPGS
FDA premarket approval P990001/S069 · decided 2010-07-15
Approval details
- PMA number
- P990001
- Supplement
- S069
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DEMA IPG/C & T SERIES IPGS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2010-05-20
- Decision date
- 2010-07-15
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPDATE TO COMPONENT PLANTING SPECIFICATION TITLED ¿MATERIAL, PLANTING, AND SURFACE FINISH REQUIREMENTS FOR TERMINALS FOR LASER RIBBON-BONDING (LRB), WIREBONDING (WB), AND PARALLEL GAP WELDING (PGW).¿ (REVISION O).
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510(k) clearances by this applicant
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|---|---|---|
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| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |