INGEVITY MRI Passive Fixation Leads, INGEVITY non-MRI Passive Fixation Leads
FDA premarket approval P150012/S063 · decided 2018-07-05
Approval details
- PMA number
- P150012
- Supplement
- S063
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INGEVITY MRI Passive Fixation Leads, INGEVITY non-MRI Passive Fixation Leads
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2018-06-11
- Decision date
- 2018-07-05
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Addition of new molding preparation equipment with updated software, application of existing overmolding equipment already in use for other leads, and duplication of existing process monitoring testing to monitor output of the added equipment.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.