MEDTRONIC.KAPPA 700/600 SERIES OF PACEMAKERS
FDA premarket approval P980035/S006 · decided 1999-12-20
Approval details
- PMA number
- P980035
- Supplement
- S006
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC.KAPPA 700/600 SERIES OF PACEMAKERS
- Applicant
- Medtronic, Inc.
- Date received
- 1999-12-06
- Decision date
- 1999-12-20
- Days to decision
- 14 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a correction to the shipping box label for the Model KDR 721 pacemaker properly identifying the contents as a "Dual Chamber Rate Responsive Pacemaker."
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