TENDRIL ST LEAD
FDA premarket approval P960013/S041 · decided 2008-12-31
Approval details
- PMA number
- P960013
- Supplement
- S041
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TENDRIL ST LEAD
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2008-12-09
- Decision date
- 2008-12-31
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- CHANGE TO ELIMINATE THE PLASMA PRIMING PROCESS.
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