PMA P960040

Device: ICD INOGEN™ VR DF4 (D010); ICD INOGEN™ VR DF1/IS1 (D011); ICD INOGEN™ DR DF4/IS1 (D012); ICD INOGEN™ DR DF1/IS1 (D013);
Applicant: Boston Scientific
PMA number: P960040
Supplement: S489
Product code: LWS
Decision date: 2026-07-23
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: to add a functionally equivalent alternate vapor degreasing solvent used to remove contaminants from pulse generator components

Current openFDA PMA Record#

Device: ICD INOGEN™ VR DF4 (D010); ICD INOGEN™ VR DF1/IS1 (D011); ICD INOGEN™ DR DF4/IS1 (D012); ICD INOGEN™ DR DF1/IS1 (D013);
Applicant: Boston Scientific
PMA number: P960040
Supplement: S516
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2026-07-23
Decision code: OK30
Date received: 2026-06-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to add a functionally equivalent alternate vapor degreasing solvent used to remove contaminants from pulse generator components