Assurity MRI; Endurity MRI; Tendril MRI
FDA premarket approval P140033/S036 · decided 2018-08-14
Approval details
- PMA number
- P140033
- Supplement
- S036
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Assurity MRI; Endurity MRI; Tendril MRI
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-07-17
- Decision date
- 2018-08-14
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Reduction in frequency of bioburden testing at the Penang, Malaysia manufacturing site.
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