MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS
FDA premarket approval P970012/S003 · decided 1998-07-14
Approval details
- PMA number
- P970012
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 1998-06-12
- Decision date
- 1998-07-14
- Days to decision
- 32 days
- Decision code
- OK30
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Requested a change in the application pattern of the epoxy ara that affixes the device battery tot he insulator cup, and an epoxy bead or fillet will be added between the battery and the hybrid.
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