Tendril MRI
FDA premarket approval P140033/S057 · decided 2020-05-22
Approval details
- PMA number
- P140033
- Supplement
- S057
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Tendril MRI
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2020-04-23
- Decision date
- 2020-05-22
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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