MEDTRONIC CAPSUREEPI PACING LEADS
FDA premarket approval P950024/S007 · decided 2006-04-04
Approval details
- PMA number
- P950024
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MEDTRONIC CAPSUREEPI PACING LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2005-12-30
- Decision date
- 2006-04-04
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE POST-APPROVAL STUDY FOR THE DEVICE.
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