MEDTRONIC KAPPA 700 SERIES OF IPGS
FDA premarket approval P980035/S024 · decided 2002-05-07
Approval details
- PMA number
- P980035
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC KAPPA 700 SERIES OF IPGS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2002-04-08
- Decision date
- 2002-05-07
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE IN THE CONTROLLED ENVIRONMENTAL AREA FROM CLASS 10,000 TO A MINIMUM OF CLASS 100,000.
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