AT500 DDDRP PACING SYSTEM
FDA premarket approval P980035/S037 · decided 2004-06-07
Approval details
- PMA number
- P980035
- Supplement
- S037
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- AT500 DDDRP PACING SYSTEM
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2004-04-16
- Decision date
- 2004-06-07
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR CHANGES TO THE INVESTIGATIONAL PLAN FOR THE MEDTRONIC'S AT500 DDDRP PACING SYSTEM'S POST-APPROVAL STUDY.
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