INGEVITY MRI LEAD, INGEVITY Non-MRI Lead
FDA premarket approval P150012/S010 · decided 2016-07-26
Approval details
- PMA number
- P150012
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INGEVITY MRI LEAD, INGEVITY Non-MRI Lead
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-07-05
- Decision date
- 2016-07-26
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Modified welding fixture for use in the manufacturing of the Ingevity family of pacemaker leads.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.