AT500DDDRP PACING SYSTEM & MODEL 9968 SOFTWARE
FDA premarket approval P980035/S027 · decided 2003-04-16
Approval details
- PMA number
- P980035
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AT500DDDRP PACING SYSTEM & MODEL 9968 SOFTWARE
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2003-03-31
- Decision date
- 2003-04-16
- Days to decision
- 16 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL TO MOVE THE MANUFACTURING SITE FROM MEDTRONIC'S EUROPEAN OPERATIONS CENTER (EOC) IN KERKRADE, THE NETHERLANDS TO MEDTRONIC'S EOC, HEERLEN, THE NETHERLANDS.
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510(k) clearances by this applicant
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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