PMA P910073S164
- Device
- REL S, REL, REL SEZ, REL EZ DUAL COIL, REL SG, REL G, SEN
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S164
- Product code
- LWS
- Decision date
- 2021-09-24
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Change the adhesive and liner used on the tray label stock for pulse generators and Leads.
Current openFDA PMA Record#
- Device
- REL S, REL, REL SEZ, REL EZ DUAL COIL, REL SG, REL G, SEN
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S164
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-09-24
- Decision code
- OK30
- Date received
- 2021-09-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the adhesive and liner used on the tray label stock for pulse generators and Leads.