MARQUIS IDC FAMILY, MAXIMO ICD FAMILY, INTRINSIC ICD FAMILY, ENTRUST ICD FAMILY
FDA premarket approval P980016/S209 · decided 2010-01-21
Approval details
- PMA number
- P980016
- Supplement
- S209
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MARQUIS IDC FAMILY, MAXIMO ICD FAMILY, INTRINSIC ICD FAMILY, ENTRUST ICD FAMILY
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-10-08
- Decision date
- 2010-01-21
- Days to decision
- 105 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
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