TENDRIL FAMILY OF LEADS
FDA premarket approval P960013/S067 · decided 2011-10-06
Approval details
- PMA number
- P960013
- Supplement
- S067
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TENDRIL FAMILY OF LEADS
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2011-09-06
- Decision date
- 2011-10-06
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- INCREASE THE LENGTH OF THE RING ELECTRODE MASKING.
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