UNIPOLAR/ LEAD END PIN CAP/OVAL PATCH LEAD
FDA premarket approval P900061/S111 · decided 2013-02-28
Approval details
- PMA number
- P900061
- Supplement
- S111
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UNIPOLAR/ LEAD END PIN CAP/OVAL PATCH LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-11-21
- Decision date
- 2013-02-28
- Days to decision
- 465 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE ACCESSORY UPSIZING SLEEVES, LEAD END PIN CAP, AND OVAL PATCH LEAD.
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