SMARTMAGNET(TM)
FDA premarket approval P980016/S013 · decided 2001-02-22
Approval details
- PMA number
- P980016
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SMARTMAGNET(TM)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2000-08-30
- Decision date
- 2001-02-22
- Days to decision
- 176 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MODEL 9322 SMARTMAGNET(TM). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SMARTMAGNET(TM) AND IS INDICATED FOR KEEPING MEDTRONIC ICDS FROM DELIVERING INAPPROPRIATE THERAPY, SUCH AS SHOCKS, TO PATIENTS DURING SURGICAL PROCEDURES THAT REQUIRE CAUTERY OR OTHER ELECTRICALLY NOISY DEVICES.
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