CAPSURE SENSE BIPOLAR LEAD
FDA premarket approval P830061/S085 · decided 2013-02-07
Approval details
- PMA number
- P830061
- Supplement
- S085
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE SENSE BIPOLAR LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-01-14
- Decision date
- 2013-02-07
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MANUFACTURING CHANGES AT THE MEDTRONIC SINGAPORE OPERATIONS (MSO) MANUFACTURING FACILITY: PROTEUS 3.6 AND SELF-TEST 3.3 FINAL FUNCTION TESTIER UPDATE, SQM VERSION 3.3.3, FACOTRYWORKS VERSION 7.8, AATS VERSION 5.0 UPDATE, AND THERMAL PROCESSING OF EPOXY RESIN.
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