PMA P910077S184
- Device
- VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S184
- Product code
- LWS
- Decision date
- 2021-05-10
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Add a new pallet sterilization chamber at the Arden Hills facility to increase sterilization capacity.
Current openFDA PMA Record#
- Device
- VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S184
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-05-10
- Decision code
- OK30
- Date received
- 2021-04-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new pallet sterilization chamber at the Arden Hills facility to increase sterilization capacity.