EVERA S DR
FDA premarket approval P980016/S411 · decided 2013-04-26
Approval details
- PMA number
- P980016
- Supplement
- S411
- Supplement type
- 30-Day Notice
- Trade name
- EVERA S DR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-04-09
- Decision date
- 2013-04-26
- Days to decision
- 17 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADDITIONAL ASSEMBLY LINE WIRE BOND WORK CELL, AND CHANGES TO LOT RELEASE TESTING AND ACCEPTANCE OF GOLD PLATED DEVICE COMPONENTS.
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