CONCERTO
FDA premarket approval P010031/S093 · decided 2008-04-03
Approval details
- PMA number
- P010031
- Supplement
- S093
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-03-04
- Decision date
- 2008-04-03
- Days to decision
- 30 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MODIFICATION OF THE INSPECTION CRITERIA FOR THE OPEN ANODE BOTTOM (OAB) AND OPEN CATHODE BOTTOM (OCB) SEPARATOR USED IN THE BATTERY OF MULTIPLE IMPLANTABLE DEVICES.
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