OPTISENSE MODEL 1999 LEAD
FDA premarket approval P960013/S057 · decided 2010-11-26
Approval details
- PMA number
- P960013
- Supplement
- S057
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPTISENSE MODEL 1999 LEAD
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-03-12
- Decision date
- 2010-11-26
- Days to decision
- 259 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR A DESIGN CHANGE TO THE HEADER COUPLING (FROM A MACHINED COMPONENT TO A MOLDED COMPONENT) OF THE OPTISENSE MODEL 1999 PACING AND SENSING LEAD.
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