ENDO RELIANCE/ S/G/SG/DF4 DEFIBRILLATION LEADS
FDA premarket approval P910073/S122 · decided 2015-11-06
Approval details
- PMA number
- P910073
- Supplement
- S122
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDO RELIANCE/ S/G/SG/DF4 DEFIBRILLATION LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2013-12-23
- Decision date
- 2015-11-06
- Days to decision
- 683 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE FOLLOWING:1) A STERILIZATION PROCESS CHANGE FROM OXYFUME TO 100% ETHYLENE OXIDE;2) DRUG SPECIFICATION CHANGES; AND3) CORRESPONDING LABELING CHANGES.
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