GEM II MODEL 7273/GEM DR 7271/GEM II VR 7229 ICDS
FDA premarket approval P980016/S008 · decided 2000-12-11
Approval details
- PMA number
- P980016
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GEM II MODEL 7273/GEM DR 7271/GEM II VR 7229 ICDS
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1999-07-26
- Decision date
- 2000-12-11
- Days to decision
- 504 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR LABELING CHANGES OF THE MEDTRONIC MODELS 7221, 7223, 7227, 7229, 7271 AND 7273.
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