ESSENTIO MRI Models: L110, L111, L131; PROPONENT MRI Models: L210, L211, L231; ACCOLADE MRI Models: L310, L311, L331
FDA premarket approval P150012/S026 · decided 2017-03-29
Approval details
- PMA number
- P150012
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ESSENTIO MRI Models: L110, L111, L131; PROPONENT MRI Models: L210, L211, L231; ACCOLADE MRI Models: L310, L311, L331
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2017-03-17
- Decision date
- 2017-03-29
- Days to decision
- 12 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Change to the method of cleaning a soldering iron tip; 2) changes to the cleaning process of the trays; 3) modification of the solder fixture; and 4) changes to the cleaning of the solder fixture.
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