RAMWARE (BASELINE 15 WITH INC5 RAMWARE) UPDATE TO THE MEDTRONIC ENTRUST 30J/35J ICD SYSTEMS
FDA premarket approval P980016/S053 · decided 2005-08-19
Approval details
- PMA number
- P980016
- Supplement
- S053
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RAMWARE (BASELINE 15 WITH INC5 RAMWARE) UPDATE TO THE MEDTRONIC ENTRUST 30J/35J ICD SYSTEMS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2005-07-29
- Decision date
- 2005-08-19
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE RAMWARE (BASELINE 15 WITH INC5 RAMWARE) UPDATE TO THE MEDTRONIC ENTRUST 30J/35J ICD SYSTEMS FOR THE FOLLOWING MODELS: MEDTRONIC ENTRUST MODEL D153ATG;MEDTRONIC ENTRUST MODEL D153DRG;MEDTRONIC ENTRUST MODEL D153VRC;MEDTRONIC ENTRUST MODEL D154ATG;MEDTRONIC ENTRUST MODEL D154DRG; ANDMEDTRONIC ENTRUST MODEL D154VRC.
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