MEDTRONIC KAPPA 700/600 PULSE GENERATOR
FDA premarket approval P980035/S010 · decided 2001-05-14
Approval details
- PMA number
- P980035
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC KAPPA 700/600 PULSE GENERATOR
- Applicant
- Medtronic, Inc.
- Date received
- 2001-04-13
- Decision date
- 2001-05-14
- Days to decision
- 31 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE EPOXY APPLICATION PATTERN AND A WIRE BOND LOOP PROGRAM IN THE ABOVE REFERENCED FAMILY OF PULSE GENERATORS.
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