Ingevity Lead Family (passive fixation models)
FDA premarket approval P150012/S069 · decided 2019-01-10
Approval details
- PMA number
- P150012
- Supplement
- S069
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Ingevity Lead Family (passive fixation models)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2018-12-20
- Decision date
- 2019-01-10
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Change the authorized laboratory for testing USP grade polyethylene glycol (PEG) 3350 and mannitol material to other service providers.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.