PMA P980023S015
- Device
- CARDIAC AIRBAG ICD, 345-424, CARDIAC AIRBAG-T ICD, 341-517, A-K00.1.U. PROGRAMMER SOFTWARE, 346-168
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S015
- Product code
- LWS
- Decision date
- 2003-10-31
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- CARDIAC AIRBAG ICD, 345-424, CARDIAC AIRBAG-T ICD, 341-517, A-K00.1.U. PROGRAMMER SOFTWARE, 346-168
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S015
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2003-10-31
- Decision code
- APPR
- Date received
- 2003-07-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.