PMA P930035S036
- Device
- Wrench Kit Model 6501
- Applicant
- Boston Scientific
- PMA number
- P930035
- Supplement
- S036
- Product code
- LWS
- Decision date
- 2026-04-10
- Classification
- Cardiovascular
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- approval for minor labeling changes, removal of paper IFU, and minor dimensional changes to sterile pouches
Current openFDA PMA Record#
- Device
- Wrench Kit Model 6501
- Applicant
- Boston Scientific
- PMA number
- P930035
- Supplement
- S036
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-04-10
- Decision code
- APPR
- Date received
- 2026-02-04
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for minor labeling changes, removal of paper IFU, and minor dimensional changes to sterile pouches