OPTISENSE RIGHT ATRIAL LEAD
FDA premarket approval P960013/S038 · decided 2009-10-01
Approval details
- PMA number
- P960013
- Supplement
- S038
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPTISENSE RIGHT ATRIAL LEAD
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2008-05-01
- Decision date
- 2009-10-01
- Days to decision
- 518 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE OPTISENSE MODEL 1999 RIGHT ATRIAL LEAD.
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