EN TRUST ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO II ICD, MAXIMO VR ICD, PROTECTA ICD,
FDA premarket approval P980016/S373 · decided 2012-08-30
Approval details
- PMA number
- P980016
- Supplement
- S373
- 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 II ICD, MAXIMO VR ICD, PROTECTA ICD,
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-08-03
- Decision date
- 2012-08-30
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MODIFICATIONS TO A CONTROLLED ENVIRONMENT.
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