EN TRUST ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO DR ICD, MAXIMO II DF4 ICD, MAXIMO II
FDA premarket approval P980016/S370 · decided 2012-08-17
Approval details
- PMA number
- P980016
- Supplement
- S370
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EN TRUST ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO DR ICD, MAXIMO II DF4 ICD, MAXIMO II
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-07-25
- Decision date
- 2012-08-17
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- NEW PRESSURE TEST EQUIPMENT USED TO VERIFY HERMETICITY.
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