PMA P910077S117
- Device
- VENTAK PRX AND VENTAK MINI AUTOMATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ACID) SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S117
- Product code
- LWS
- Decision date
- 2011-09-01
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- CHANGE TO A CONTRACT MANUFACTURERS SOLDER STENCIL AND PICK-AND-PLACE EQUIPMENT.
Current openFDA PMA Record#
- Device
- VENTAK PRX AND VENTAK MINI AUTOMATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ACID) SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S117
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2011-09-01
- Decision code
- OK30
- Date received
- 2011-08-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO A CONTRACT MANUFACTURERS SOLDER STENCIL AND PICK-AND-PLACE EQUIPMENT.