OPTISENSE 1999 LEAD
FDA premarket approval P960013/S058 · decided 2010-05-19
Approval details
- PMA number
- P960013
- Supplement
- S058
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OPTISENSE 1999 LEAD
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-03-23
- Decision date
- 2010-05-19
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR NEW STYLETS TO BE INCLUDED IN THE OPTISENSE MODEL 1999 LEAD PACKAGE.
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