GEM & GEM II VR
FDA premarket approval P900061/S078 · decided 2008-09-10
Approval details
- PMA number
- P900061
- Supplement
- S078
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GEM & GEM II VR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-08-11
- Decision date
- 2008-09-10
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADDITION FO AN ETO STERILIZER AT THE TOLOCHENAZ, SWITZERLAND FACILITY AND CHANGES TO THE ETHYLENE OXIDE STERILIZATION LETHALITY MODEL. THE ADDITION OF THE ETO STERILIZER IS NOT APPLICABLE TO THE FOLLOWING DEVICES: CONSULTA, MAXIMO II, SECURA DR/VR FAMILY, AND MAXIMO II DDR/VR FAMILY.
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