MEDTRONIC INTRINSIC MODELS 7287 AND 7288 ICD SYSTEMS
FDA premarket approval P980016/S043 · decided 2004-08-18
Approval details
- PMA number
- P980016
- Supplement
- S043
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC INTRINSIC MODELS 7287 AND 7288 ICD SYSTEMS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2004-07-07
- Decision date
- 2004-08-18
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A RAMWARE UPDATE TO THE MEDTRONIC INTRINSIC MODELS 7287 AND 7288 ICD SYSTEMS.
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