AtriCure Isolator Clamp, AtriCure Long Clamp, AtriCure Synergy Clamp
FDA premarket approval P100046/S015 · decided 2023-03-23
Approval details
- PMA number
- P100046
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AtriCure Isolator Clamp, AtriCure Long Clamp, AtriCure Synergy Clamp
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2023-02-21
- Decision date
- 2023-03-23
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- Alternative epoxy backfilling process to be used on the overmolded insulators found on the sterile OSL2 and OLL2 handpieces.
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