MARQUIS, MAXIMO, INTRINSIC FAMILY, ONYX, VIRTUOSO, ENTRUST FAMILY,
FDA premarket approval P980016/S122 · decided 2008-02-21
Approval details
- PMA number
- P980016
- Supplement
- S122
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MARQUIS, MAXIMO, INTRINSIC FAMILY, ONYX, VIRTUOSO, ENTRUST FAMILY,
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-01-25
- Decision date
- 2008-02-21
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE IN THE CLEANING PROCESS FOR TITANIUM SHIELDS AT MEDTRONIC APPROVED SUPPLIER, GTM GLOBE.
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