ESSENTIO MRI SR, ESSENTIO MRI DR, PROPONENT MRI SR, PROPONENT MRI DR, ACCOLADE MRI SR, ACCOLADE MRI DR, INGEVITY PLUS AF
FDA premarket approval P150012/S117 · decided 2021-09-24
Approval details
- PMA number
- P150012
- Supplement
- S117
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ESSENTIO MRI SR, ESSENTIO MRI DR, PROPONENT MRI SR, PROPONENT MRI DR, ACCOLADE MRI SR, ACCOLADE MRI DR, INGEVITY PLUS AF
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2021-09-23
- Decision date
- 2021-09-24
- Days to decision
- 1 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Change the adhesive and liner used on the tray label stock for pulse generators and 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.