TENDRIL STS
FDA premarket approval P960013/S065 · decided 2011-06-28
Approval details
- PMA number
- P960013
- Supplement
- S065
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TENDRIL STS
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2011-05-18
- Decision date
- 2011-06-28
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO LLC IN ARECIBO, PUERTO RICO.
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