MEDTRONIC ENTRUST 35J ICD (D154ATG, D15DRG. D154VRC) MEDTRONIC VIRTUOSO ICD (D154AWG, D154VWC)
FDA premarket approval P980016/S099 · decided 2007-08-07
Approval details
- PMA number
- P980016
- Supplement
- S099
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC ENTRUST 35J ICD (D154ATG, D15DRG. D154VRC) MEDTRONIC VIRTUOSO ICD (D154AWG, D154VWC)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-04-02
- Decision date
- 2007-08-07
- Days to decision
- 127 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A CHANGE TO THE CAPACITOR PERIMETER INSULATION TAPE.
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