MEDTRONIC KAPPA 700/600/800/900 PULSE GENERATORS
FDA premarket approval P980035/S023 · decided 2002-03-15
Approval details
- PMA number
- P980035
- Supplement
- S023
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC KAPPA 700/600/800/900 PULSE GENERATORS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2002-03-12
- Decision date
- 2002-03-15
- Days to decision
- 3 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR TWO CHANGES IN THE MANUFACTURING PROCESS INVOLVING THE EPOXY DISPENSE PROGRAM AND THE WIRE BOND LOOP PROGRAM.
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