RELIANCE 4-FRONT Steroid-eluting Pace/Sense and Defibrillation Lead
FDA premarket approval P910073/S162 · decided 2021-06-08
Approval details
- PMA number
- P910073
- Supplement
- S162
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RELIANCE 4-FRONT Steroid-eluting Pace/Sense and Defibrillation Lead
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2021-05-25
- Decision date
- 2021-06-08
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Add a visual inspection to the defibrillation lead connector terminal subassembly.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.