MEDTRONIC KAPPA 400 SERIES IPG'S
FDA premarket approval P970012/S008 · decided 1999-03-12
Approval details
- PMA number
- P970012
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC KAPPA 400 SERIES IPG'S
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 1998-09-24
- Decision date
- 1999-03-12
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a manufacturing site located at Medtronic Europe S.A., Route de Molliau, Tolochenaz, Switzerland and a final packaging site located at Medtronic B.V., Kerkrade, Wenckebachstraat 10, 6466, Postbus, 1013-6460 BA, Kerkrade, The Netherlands.
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