INGEVITY Active-Fixation Non-MRI / Active-Fixation MRI
FDA premarket approval P150012/S038 · decided 2017-10-05
Approval details
- PMA number
- P150012
- Supplement
- S038
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INGEVITY Active-Fixation Non-MRI / Active-Fixation MRI
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2017-09-05
- Decision date
- 2017-10-05
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Modifications to improve the helix to coupler weld process and implement tighter control at the proximal end of the tip helix component.
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