PMA P910077S081
- Device
- VENTAK MINI & CONTAK RENEWAL 3
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S081
- Product code
- LWS
- Decision date
- 2007-12-05
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- CHANGES TO THE SEAL PLUG BONDING CURING PROCESS.
Current openFDA PMA Record#
- Device
- VENTAK MINI & CONTAK RENEWAL 3
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S081
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2007-12-05
- Decision code
- OK30
- Date received
- 2007-11-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE SEAL PLUG BONDING CURING PROCESS.