RELIANCE 4-FRONT
FDA premarket approval P910073/S178 · decided 2024-05-22
Approval details
- PMA number
- P910073
- Supplement
- S178
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RELIANCE 4-FRONT
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2024-04-22
- Decision date
- 2024-05-22
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- to add a mold release agent and cleaning step to lead terminal overmold process
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